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Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Adhesive bandage". It is used for to protect small cuts and abrasions on intact skin from contaminants and support healing. and generally comes into contact with intact skin. The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Adhesive bandage** — To protect small cuts and abrasions on intact skin from contaminants and support healing..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12021
UMDNS Category: Bandages, Adhesive
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Medical face mask (non-sterile)" has the following use: To limit the transmission of airborne particles from the wearer to the environment.. It touches Intact skin and is not implantable. It is not active and is not sterile.
|
<think>
Analyzing the device: **Medical face mask (non-sterile)** — To limit the transmission of airborne particles from the wearer to the environment..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12247
UMDNS Category: Masks, Surgical
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Patient gown", is described as to maintain hygiene and allow access during clinical procedures.. It’s non-invasive, intended for short term use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Patient gown** — To maintain hygiene and allow access during clinical procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14955
UMDNS Category: Gowns, Patient
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Eye patch". Purpose: To protect the eye postoperatively or during healing of non-infectious eye conditions.. Contact type: Intact skin. Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Eye patch** — To protect the eye postoperatively or during healing of non-infectious eye conditions..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12165
UMDNS Category: Patches, Eye
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Surgical drape". It is typically non-invasive, not implantable, and used for to isolate the surgical site from surrounding areas to reduce risk of infection..
|
<think>
Analyzing the device: **Surgical drape** — To isolate the surgical site from surrounding areas to reduce risk of infection..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 16261
UMDNS Category: Drapes, Surgical
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Compression stocking" should be classified. It serves to to apply graduated pressure to the legs and improve venous return., is non-invasive, and usually touches intact skin surfaces.
|
<think>
Analyzing the device: **Compression stocking** — To apply graduated pressure to the legs and improve venous return..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 10489
UMDNS Category: Stockings, Compression
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Wheelchair cushion (non-powered)". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To prevent pressure ulcers by relieving pressure in seated individuals..
|
<think>
Analyzing the device: **Wheelchair cushion (non-powered)** — To prevent pressure ulcers by relieving pressure in seated individuals..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14677
UMDNS Category: Cushions, Wheelchair
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Heel protector", is under evaluation. No known active function. It’s sterile: No, and software status is: No.
|
<think>
Analyzing the device: **Heel protector** — To prevent pressure injuries in bedridden patients by cushioning the heel..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 16960
UMDNS Category: Protectors, Heel
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Non-sterile examination gloves". The product is used to to protect the wearer from contamination during patient examination.. It is sterile: No, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Non-sterile examination gloves** — To protect the wearer from contamination during patient examination..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12286
UMDNS Category: Gloves, Examination
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Thermal therapy pad (non-electric)". It does not go inside the body and is intended for to relieve pain or stiffness by applying heat to the skin..
|
<think>
Analyzing the device: **Thermal therapy pad (non-electric)** — To relieve pain or stiffness by applying heat to the skin..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14263
UMDNS Category: Wraps, Heat Therapy
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
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I'm reviewing the device "Urine collection bag with anti-reflux valve". It is used for to collect urine via catheter with prevention of backflow into the urinary tract. and generally comes into contact with body fluid (via catheter). The device is classified as non-invasive (but connected to invasive), not active, and sterile.
|
<think>
Analyzing the device: **Urine collection bag with anti-reflux valve** — To collect urine via catheter with prevention of backflow into the urinary tract..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 17450
UMDNS Category: Bags, Urine Collection
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Conductive ultrasound gel with added cooling agent" has the following use: To enable ultrasound transmission and cool the surface during thermal imaging procedures.. It touches Intact skin and is not implantable. It is not active and is not sterile.
|
<think>
Analyzing the device: **Conductive ultrasound gel with added cooling agent** — To enable ultrasound transmission and cool the surface during thermal imaging procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14290
UMDNS Category: Gels, Ultrasonic Coupling
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Patient transfer sheet", is described as to assist in moving a patient across a bed or stretcher without friction or lifting.. It’s non-invasive, intended for transient use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Patient transfer sheet** — To assist in moving a patient across a bed or stretcher without friction or lifting..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14410
UMDNS Category: Sheets, Transfer
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Hospital bed (manual)". Purpose: To support patients in lying or reclining positions during recovery or treatment.. Contact type: Intact skin. Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Hospital bed (manual)** — To support patients in lying or reclining positions during recovery or treatment..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 10834
UMDNS Category: Beds, Hospital, Manual
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Walking frame (non-wheeled)". It is typically non-invasive, not implantable, and used for to assist mobility for individuals with limited balance or strength..
|
<think>
Analyzing the device: **Walking frame (non-wheeled)** — To assist mobility for individuals with limited balance or strength..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14865
UMDNS Category: Walkers
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Dental patient chair (non-powered)" should be classified. It serves to to support the patient in a stable seated or reclined position during dental procedures., is non-invasive, and usually touches back and legs surfaces.
|
<think>
Analyzing the device: **Dental patient chair (non-powered)** — To support the patient in a stable seated or reclined position during dental procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12697
UMDNS Category: Chairs, Dental, Patient
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Foam positioner block". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To provide ergonomic support for body parts during medical imaging or therapy..
|
<think>
Analyzing the device: **Foam positioner block** — To provide ergonomic support for body parts during medical imaging or therapy..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
✔️ This rule applies because: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 1 applies — Devices that either do not come in direct contact with the patient or contact intact skin only.
The device clearly matches the criteria of Rule Rule 1, as it all non-invasive devices are classified as class i, unless one of the rules set out hereinafter applies.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 1 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13189
UMDNS Category: Positioners, Patient
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Infusion pump tubing", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Infusion pump tubing** — To channel intravenous fluids from an infusion pump to the patient..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 13965
UMDNS Category: Tubing, Infusion
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Blood transfusion set". The product is used to to channel blood from a blood bag to the patient's venous system during transfusion.. It is sterile: Yes, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Blood transfusion set** — To channel blood from a blood bag to the patient's venous system during transfusion..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10894
UMDNS Category: Sets, Transfusion
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Syringe for infusion pump". It does not go inside the body and is intended for to administer fluids at a controlled rate via an infusion pump..
|
<think>
Analyzing the device: **Syringe for infusion pump** — To administer fluids at a controlled rate via an infusion pump..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 16847
UMDNS Category: Syringes, Pump
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Anaesthesia breathing circuit". It is used for to channel anesthetic gases between the machine and patient during surgery. and generally comes into contact with gas (respiratory). The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Anaesthesia breathing circuit** — To channel anesthetic gases between the machine and patient during surgery..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10114
UMDNS Category: Circuits, Anesthesia Breathing
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Blood storage bag" has the following use: To store blood for transfusion under sterile conditions.. It touches Blood and is not implantable. It is not active and is sterile.
|
<think>
Analyzing the device: **Blood storage bag** — To store blood for transfusion under sterile conditions..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10103
UMDNS Category: Bags, Blood Collection/Storage
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Organ transport container", is described as to temporarily store and preserve organs during transportation for transplantation.. It’s non-invasive, intended for short term use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Organ transport container** — To temporarily store and preserve organs during transportation for transplantation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 17499
UMDNS Category: Containers, Organ Preservation
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Antistatic tubing for anaesthesia". Purpose: To channel anesthetic gases and prevent static electricity in the gas pathway.. Contact type: Gas (non-invasive). Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Antistatic tubing for anaesthesia** — To channel anesthetic gases and prevent static electricity in the gas pathway..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 11313
UMDNS Category: Tubing, Anesthesia, Antistatic
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Enteral feeding tube (non-invasive part)". It is typically non-invasive portion, not implantable, and used for to channel nutritional liquid from a pump to a nasogastric tube..
|
<think>
Analyzing the device: **Enteral feeding tube (non-invasive part)** — To channel nutritional liquid from a pump to a nasogastric tube..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 11878
UMDNS Category: Sets, Enteral Feeding
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Saline irrigation bag (gravity-fed)" should be classified. It serves to to provide sterile saline for wound irrigation by gravity flow., is non-invasive, and usually touches saline (body contact after flow) surfaces.
|
<think>
Analyzing the device: **Saline irrigation bag (gravity-fed)** — To provide sterile saline for wound irrigation by gravity flow..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 14877
UMDNS Category: Bags, Irrigation
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "IV pressure bag (non-electronic)". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To apply manual pressure on IV fluids to accelerate infusion..
|
<think>
Analyzing the device: **IV pressure bag (non-electronic)** — To apply manual pressure on IV fluids to accelerate infusion..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - first indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - first indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 2 - first indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - first indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 17589
UMDNS Category: Bags, IV Pressure
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Standard blood bag without anticoagulant", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Standard blood bag without anticoagulant** — To collect, store and transport human blood for transfusion without integrated medicinal substances..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10103
UMDNS Category: Bags, Blood Collection/Storage
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Quadruple blood bag system". The product is used to to collect and separate blood into components without any medicinal additives.. It is sterile: Yes, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Quadruple blood bag system** — To collect and separate blood into components without any medicinal additives..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10103
UMDNS Category: Bags, Blood Collection/Storage
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Leukoreduction blood bag". It does not go inside the body and is intended for to filter out leukocytes from donated blood for transfusion, no medicinal substance included..
|
<think>
Analyzing the device: **Leukoreduction blood bag** — To filter out leukocytes from donated blood for transfusion, no medicinal substance included..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 18257
UMDNS Category: Bags, Blood, Leukocyte-Reducing
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Blood mixing and transfer bag". It is used for to mix and transfer blood from donor to storage without drug additives. and generally comes into contact with blood. The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Blood mixing and transfer bag** — To mix and transfer blood from donor to storage without drug additives..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10893
UMDNS Category: Sets, Blood Collection
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Plasma separation bag" has the following use: To store plasma separated from whole blood in a sterile environment without any drug content.. It touches Blood/plasma and is not implantable. It is not active and is sterile.
|
<think>
Analyzing the device: **Plasma separation bag** — To store plasma separated from whole blood in a sterile environment without any drug content..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 16999
UMDNS Category: Bags, Plasma Collection
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Platelet storage bag", is described as to store platelets derived from centrifuged whole blood, without active ingredients.. It’s non-invasive, intended for short term use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Platelet storage bag** — To store platelets derived from centrifuged whole blood, without active ingredients..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 17691
UMDNS Category: Bags, Platelet Storage
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Sterile transfer pack". Purpose: To transfer blood components between containers without contamination or medication.. Contact type: Blood. Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Sterile transfer pack** — To transfer blood components between containers without contamination or medication..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 17654
UMDNS Category: Packs, Transfer, Blood
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Cryopreservation bag for blood". It is typically non-invasive, not implantable, and used for to store blood or its components under freezing conditions, without drugs..
|
<think>
Analyzing the device: **Cryopreservation bag for blood** — To store blood or its components under freezing conditions, without drugs..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 17692
UMDNS Category: Bags, Blood Cryopreservation
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Autotransfusion collection bag" should be classified. It serves to to collect and temporarily store a patient’s own blood during surgery for reinfusion., is non-invasive, and usually touches blood surfaces.
|
<think>
Analyzing the device: **Autotransfusion collection bag** — To collect and temporarily store a patient’s own blood during surgery for reinfusion..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 10899
UMDNS Category: Sets, Autotransfusion
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Cord blood collection bag". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To collect umbilical cord blood for stem cell storage without added drugs..
|
<think>
Analyzing the device: **Cord blood collection bag** — To collect umbilical cord blood for stem cell storage without added drugs..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - second indent applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - second indent, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 2 - second indent – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - second indent fits based on device contact type, functionality, and intended use.
UMDNS Code: 17693
UMDNS Category: Bags, Blood, Umbilical Cord
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Gravity infusion administration set", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Gravity infusion administration set** — To administer IV fluids to a patient using gravity, without any pumping or regulation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 16781
UMDNS Category: Sets, Administration, IV, Gravity-Fed
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Oral medicine spoon". The product is used to to temporarily hold and deliver measured doses of liquid medication by mouth.. It is sterile: No, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Oral medicine spoon** — To temporarily hold and deliver measured doses of liquid medication by mouth..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 12345
UMDNS Category: Spoons, Oral Dosing
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Plastic medicine cup". It does not go inside the body and is intended for to measure and temporarily contain liquid or solid medication for oral administration..
|
<think>
Analyzing the device: **Plastic medicine cup** — To measure and temporarily contain liquid or solid medication for oral administration..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 14456
UMDNS Category: Cups, Medication
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Empty plastic syringe (no needle)". It is used for to aspirate or deliver fluid by manual pressure without penetration or drug preloading. and generally comes into contact with body fluid (external/injection port only). The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Empty plastic syringe (no needle)** — To aspirate or deliver fluid by manual pressure without penetration or drug preloading..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 16845
UMDNS Category: Syringes, General Purpose
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Medicine dropper" has the following use: To deliver small, measured amounts of liquid orally or ophthalmically by gravity.. It touches Mucosa (oral or eye) and is not implantable. It is not active and is not sterile.
|
<think>
Analyzing the device: **Medicine dropper** — To deliver small, measured amounts of liquid orally or ophthalmically by gravity..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 10209
UMDNS Category: Droppers, Eye/Oral
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Irrigation bottle", is described as to deliver sterile fluid by gravity flow to irrigate wounds or surgical sites.. It’s non-invasive, intended for transient use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Irrigation bottle** — To deliver sterile fluid by gravity flow to irrigate wounds or surgical sites..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 12662
UMDNS Category: Bottles, Irrigation
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Feeding cup for neonates". Purpose: To assist in oral feeding of neonates by storing and dispensing expressed breastmilk or formula.. Contact type: Oral mucosa. Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Feeding cup for neonates** — To assist in oral feeding of neonates by storing and dispensing expressed breastmilk or formula..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 10023
UMDNS Category: Cups, Feeding, Neonatal
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Powder medication scoop". It is typically non-invasive, not implantable, and used for to measure and transport powdered medication for oral administration..
|
<think>
Analyzing the device: **Powder medication scoop** — To measure and transport powdered medication for oral administration..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 14459
UMDNS Category: Scoops, Medication
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Eye bath cup" should be classified. It serves to to rinse the eye surface with sterile fluid using gravity-assisted flow., is non-invasive, and usually touches eye surface surfaces.
|
<think>
Analyzing the device: **Eye bath cup** — To rinse the eye surface with sterile fluid using gravity-assisted flow..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 18277
UMDNS Category: Cups, Eye
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Flexible collection pouch". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To collect body fluids discharged from wounds using gravity drainage..
|
<think>
Analyzing the device: **Flexible collection pouch** — To collect body fluids discharged from wounds using gravity drainage..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
✔️ This rule applies because: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 2 - Base case applies — Channelling or storing for eventual administration.
The device clearly matches the criteria of Rule Rule 2 - Base case, as it all non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or introduction into the body are classified as class iia:
— if they may be connected to a class iia, class iib or class iii active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts
of organs or body cells and tissues, except for blood bags; blood bags are classified as class iib.
in all other cases, such devices are classified as class i.
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 2 - Base case – Channelling or storing for eventual administration
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 2 - Base case fits based on device contact type, functionality, and intended use.
UMDNS Code: 17703
UMDNS Category: Pouches, Drainage
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Hemodialyzer", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Hemodialyzer** — To remove waste products, excess substances, and water from the blood of patients with kidney failure via diffusion and ultrafiltration..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11052
UMDNS Category: Dialyzers, Hemodialysis
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Hemodialysis concentrate". The product is used to to prepare dialysate solution used in hemodialysis to regulate the concentration of electrolytes and waste product removal.. It is sterile: No, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Hemodialysis concentrate** — To prepare dialysate solution used in hemodialysis to regulate the concentration of electrolytes and waste product removal..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13306
UMDNS Category: Concentrates, Dialysis
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Plasmapheresis separator". It does not go inside the body and is intended for to separate plasma from whole blood in therapeutic or donor plasmapheresis procedures..
|
<think>
Analyzing the device: **Plasmapheresis separator** — To separate plasma from whole blood in therapeutic or donor plasmapheresis procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11186
UMDNS Category: Separators, Plasma
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Column for selective blood cell removal". It is used for to selectively remove activated or targeted blood cells (e.g. leukocytes) by affinity binding to a surface matrix. and generally comes into contact with blood. The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Column for selective blood cell removal** — To selectively remove activated or targeted blood cells (e.g. leukocytes) by affinity binding to a surface matrix..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 18300
UMDNS Category: Filters, Blood, Cell-Specific Removal
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Gradient medium for sperm separation" has the following use: To enable physical separation of motile sperm from non-viable sperm and debris for assisted reproduction.. It touches Human cells (sperm) and is not implantable. It is not active and is sterile.
|
<think>
Analyzing the device: **Gradient medium for sperm separation** — To enable physical separation of motile sperm from non-viable sperm and debris for assisted reproduction..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13652
UMDNS Category: Media, Cell Separation
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Activated carbon hemoperfusion cartridge", is described as to adsorb toxins and harmful substances from the blood during hemoperfusion treatment.. It’s non-invasive, intended for short term use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Activated carbon hemoperfusion cartridge** — To adsorb toxins and harmful substances from the blood during hemoperfusion treatment..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 17698
UMDNS Category: Cartridges, Hemoperfusion
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Endotoxin removal filter". Purpose: To remove circulating endotoxins from blood in septic shock patients using a selective membrane.. Contact type: Blood. Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Endotoxin removal filter** — To remove circulating endotoxins from blood in septic shock patients using a selective membrane..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 18301
UMDNS Category: Filters, Endotoxin Removal
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Plasma exchange column". It is typically non-invasive, not implantable, and used for to exchange patient plasma with replacement fluids to remove autoantibodies or abnormal proteins..
|
<think>
Analyzing the device: **Plasma exchange column** — To exchange patient plasma with replacement fluids to remove autoantibodies or abnormal proteins..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11189
UMDNS Category: Columns, Plasma Exchange
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Cytokine adsorption cartridge" should be classified. It serves to to selectively adsorb cytokines from blood in hyperinflammatory syndromes such as sepsis., is non-invasive, and usually touches blood surfaces.
|
<think>
Analyzing the device: **Cytokine adsorption cartridge** — To selectively adsorb cytokines from blood in hyperinflammatory syndromes such as sepsis..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 18302
UMDNS Category: Cartridges, Cytokine Removal
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Urea removal dialysate filter". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To regulate and purify dialysate fluid by removing urea and other metabolic waste before contact with patient blood..
|
<think>
Analyzing the device: **Urea removal dialysate filter** — To regulate and purify dialysate fluid by removing urea and other metabolic waste before contact with patient blood..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 18303
UMDNS Category: Filters, Dialysate, Urea Removal
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Particulate blood filter (extracorporeal)", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Particulate blood filter (extracorporeal)** — To remove microemboli and particulate contaminants from the patient's blood during cardiopulmonary bypass procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11193
UMDNS Category: Filters, Blood
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Autotransfusion centrifuge". The product is used to to centrifuge a patient's own blood collected during surgery and separate red blood cells for reinfusion.. It is sterile: No (reusable base unit), active: Yes (centrifuge), invasive: Non-invasive.
|
<think>
Analyzing the device: **Autotransfusion centrifuge** — To centrifuge a patient's own blood collected during surgery and separate red blood cells for reinfusion..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 10899
UMDNS Category: Sets, Autotransfusion
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Blood gas exchanger (membrane oxygenator)". It does not go inside the body and is intended for to remove carbon dioxide and add oxygen to the blood in an extracorporeal circulation system, such as during open-heart surgery..
|
<think>
Analyzing the device: **Blood gas exchanger (membrane oxygenator)** — To remove carbon dioxide and add oxygen to the blood in an extracorporeal circulation system, such as during open-heart surgery..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 10890
UMDNS Category: Oxygenators, Membrane
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Blood warmer for extracorporeal use". It is used for to warm blood during extracorporeal circulation to maintain normothermia in surgical patients. and generally comes into contact with blood. The device is classified as non-invasive, active, and non-sterile.
|
<think>
Analyzing the device: **Blood warmer for extracorporeal use** — To warm blood during extracorporeal circulation to maintain normothermia in surgical patients..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11030
UMDNS Category: Warmers, Blood, Extracorporeal
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Blood cooler (perfusion cooling unit)" has the following use: To reduce the temperature of blood in extracorporeal circulation to induce hypothermia during surgery.. It touches Blood and is not implantable. It is active and is sterile.
|
<think>
Analyzing the device: **Blood cooler (perfusion cooling unit)** — To reduce the temperature of blood in extracorporeal circulation to induce hypothermia during surgery..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11031
UMDNS Category: Coolers, Blood, Extracorporeal
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Red cell washing centrifuge", is described as to wash and remove plasma proteins and electrolytes from donor red blood cells prior to transfusion using centrifugation.. It’s non-invasive, intended for short term use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Red cell washing centrifuge** — To wash and remove plasma proteins and electrolytes from donor red blood cells prior to transfusion using centrifugation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 17690
UMDNS Category: Centrifuges, Cell Washing
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Plasma filter (non-cellular component filter)". Purpose: To filter plasma from whole blood in extracorporeal plasma separation therapies.. Contact type: Plasma (blood component). Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Plasma filter (non-cellular component filter)** — To filter plasma from whole blood in extracorporeal plasma separation therapies..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11192
UMDNS Category: Filters, Plasma
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Portable extracorporeal blood heater". It is typically non-invasive, not implantable, and used for to raise the temperature of blood outside the body for emergency transfusion and warming applications in field or transport settings..
|
<think>
Analyzing the device: **Portable extracorporeal blood heater** — To raise the temperature of blood outside the body for emergency transfusion and warming applications in field or transport settings..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11030
UMDNS Category: Warmers, Blood, Extracorporeal
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Extracorporeal heat exchanger" should be classified. It serves to to regulate temperature by transferring heat between blood and a thermal medium in a bypass circuit., is non-invasive, and usually touches blood surfaces.
|
<think>
Analyzing the device: **Extracorporeal heat exchanger** — To regulate temperature by transferring heat between blood and a thermal medium in a bypass circuit..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 11032
UMDNS Category: Exchangers, Heat, Extracorporeal
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Gas exchanger with integrated sensor". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To facilitate oxygenation and CO? removal while monitoring gas transfer efficiency in extracorporeal systems..
|
<think>
Analyzing the device: **Gas exchanger with integrated sensor** — To facilitate oxygenation and CO? removal while monitoring gas transfer efficiency in extracorporeal systems..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 10890
UMDNS Category: Oxygenators, Membrane
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Embryo culture medium", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Embryo culture medium** — To provide a controlled environment supporting the growth and development of human embryos in vitro prior to implantation in assisted reproduction procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13588
UMDNS Category: Media, Embryo Culture
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Sperm preparation medium". The product is used to to prepare and purify spermatozoa for use in ivf/icsi by direct contact separation and washing of motile sperm.. It is sterile: Yes, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Sperm preparation medium** — To prepare and purify spermatozoa for use in IVF/ICSI by direct contact separation and washing of motile sperm..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13589
UMDNS Category: Media, Sperm Preparation
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Oocyte freezing solution". It does not go inside the body and is intended for cryoprotective solution intended to preserve human oocytes via vitrification prior to ivf procedures..
|
<think>
Analyzing the device: **Oocyte freezing solution** — Cryoprotective solution intended to preserve human oocytes via vitrification prior to IVF procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13591
UMDNS Category: Solutions, Cryopreservation
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Embryo thawing media". It is used for to rehydrate and gradually warm previously cryopreserved human embryos for implantation in art procedures. and generally comes into contact with human embryo (in vitro). The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Embryo thawing media** — To rehydrate and gradually warm previously cryopreserved human embryos for implantation in ART procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13592
UMDNS Category: Media, Embryo Thawing
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "ICSI buffer solution" has the following use: To maintain pH and osmolarity during intracytoplasmic sperm injection (ICSI) into oocytes for fertilization.. It touches Human gametes (in vitro) and is not implantable. It is not active and is sterile.
|
<think>
Analyzing the device: **ICSI buffer solution** — To maintain pH and osmolarity during intracytoplasmic sperm injection (ICSI) into oocytes for fertilization..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13590
UMDNS Category: Buffers, ICSI
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Blastocyst culture medium", is described as to support extended culture of human embryos to the blastocyst stage prior to implantation.. It’s non-invasive, intended for short term use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Blastocyst culture medium** — To support extended culture of human embryos to the blastocyst stage prior to implantation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13593
UMDNS Category: Media, Blastocyst Culture
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Embryo biopsy buffer". Purpose: To preserve embryo viability during biopsy and removal of cells for preimplantation genetic testing (PGT).. Contact type: Human embryo (in vitro). Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Embryo biopsy buffer** — To preserve embryo viability during biopsy and removal of cells for preimplantation genetic testing (PGT)..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13594
UMDNS Category: Buffers, Embryo Biopsy
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Zona pellucida digestion enzyme". It is typically non-invasive, not implantable, and used for to assist in embryo hatching or biopsy by enzymatically thinning the zona pellucida in vitro before implantation..
|
<think>
Analyzing the device: **Zona pellucida digestion enzyme** — To assist in embryo hatching or biopsy by enzymatically thinning the zona pellucida in vitro before implantation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13595
UMDNS Category: Enzymes, Embryo Manipulation
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Human tissue transport medium" should be classified. It serves to to maintain the viability of excised human tissues (e.g. ovarian tissue, corneal grafts) for use in regenerative or transplant procedures., is non-invasive, and usually touches human tissue (in vitro) surfaces.
|
<think>
Analyzing the device: **Human tissue transport medium** — To maintain the viability of excised human tissues (e.g. ovarian tissue, corneal grafts) for use in regenerative or transplant procedures..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13596
UMDNS Category: Media, Tissue Transport
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Organ culture solution". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To preserve excised human organs (e.g. kidney, liver) for temporary ex vivo storage and treatment before implantation..
|
<think>
Analyzing the device: **Organ culture solution** — To preserve excised human organs (e.g. kidney, liver) for temporary ex vivo storage and treatment before implantation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
✔️ This rule applies because: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
❌ Not applicable: It does not treat wounds or injured skin.
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 3 applies — Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body.
The device clearly matches the criteria of Rule Rule 3, as it all non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class iib, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class iia. all non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class iii.
</think>
Risk Class: Class III
Applicable Rule: Rule Rule 3 – Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 3 fits based on device contact type, functionality, and intended use.
UMDNS Code: 13597
UMDNS Category: Solutions, Organ Culture
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Absorbent wound pad", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Absorbent wound pad** — To provide a sterile, non-adherent surface for the absorption of wound exudate and to protect the injured skin from external contamination..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12296
UMDNS Category: Pads, Wound
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Island dressing". The product is used to to cover and protect post-operative or traumatic wounds while absorbing exudate and providing a sterile healing environment.. It is sterile: Yes, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Island dressing** — To cover and protect post-operative or traumatic wounds while absorbing exudate and providing a sterile healing environment..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12306
UMDNS Category: Dressings, Island
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Cotton wool roll". It does not go inside the body and is intended for to protect injured skin and absorb wound exudate, commonly used in minor wound care and padding applications..
|
<think>
Analyzing the device: **Cotton wool roll** — To protect injured skin and absorb wound exudate, commonly used in minor wound care and padding applications..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12866
UMDNS Category: Cotton, Absorbent
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Adhesive bandage (band-aid)". It is used for to protect minor cuts, abrasions, or wounds and absorb exudate through an attached sterile pad. and generally comes into contact with injured skin. The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Adhesive bandage (band-aid)** — To protect minor cuts, abrasions, or wounds and absorb exudate through an attached sterile pad..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12300
UMDNS Category: Bandages, Adhesive
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Wound closure strip" has the following use: To approximate and secure the edges of small, shallow wounds and lacerations to facilitate healing.. It touches Injured skin and is not implantable. It is not active and is sterile.
|
<think>
Analyzing the device: **Wound closure strip** — To approximate and secure the edges of small, shallow wounds and lacerations to facilitate healing..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12298
UMDNS Category: Strips, Wound Closure
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Ostomy bag", is described as to collect body waste from a surgically diverted biological system (e.g., colostomy, ileostomy) via an abdominal stoma.. It’s non-invasive, intended for prolonged use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Ostomy bag** — To collect body waste from a surgically diverted biological system (e.g., colostomy, ileostomy) via an abdominal stoma..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 14800
UMDNS Category: Bags, Ostomy
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Sterile gauze swab". Purpose: To clean or cover wounds, absorb exudate, or apply antiseptics while maintaining a sterile wound environment.. Contact type: Injured skin. Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Sterile gauze swab** — To clean or cover wounds, absorb exudate, or apply antiseptics while maintaining a sterile wound environment..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12867
UMDNS Category: Gauze, Surgical
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Non-woven wound dressing". It is typically non-invasive, not implantable, and used for to act as a protective barrier and absorbent layer for low to moderately exuding wounds..
|
<think>
Analyzing the device: **Non-woven wound dressing** — To act as a protective barrier and absorbent layer for low to moderately exuding wounds..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12301
UMDNS Category: Dressings, Nonwoven
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Foam wound dressing (non-medicated)" should be classified. It serves to to absorb moderate levels of wound exudate and provide a moist healing environment for superficial wounds., is non-invasive, and usually touches injured skin surfaces.
|
<think>
Analyzing the device: **Foam wound dressing (non-medicated)** — To absorb moderate levels of wound exudate and provide a moist healing environment for superficial wounds..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12302
UMDNS Category: Dressings, Foam
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Pressure dressing bandage". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To apply mechanical compression to control bleeding or swelling in soft tissue injuries..
|
<think>
Analyzing the device: **Pressure dressing bandage** — To apply mechanical compression to control bleeding or swelling in soft tissue injuries..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class I
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12299
UMDNS Category: Bandages, Pressure
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Hydrocolloid dressing for chronic ulcers", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Hydrocolloid dressing for chronic ulcers** — To provide a moist environment and support autolytic debridement for deep pressure ulcers or diabetic foot ulcers healing by secondary intent..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12310
UMDNS Category: Dressings, Hydrocolloid
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Alginate dressing for exuding wounds". The product is used to to absorb heavy exudate and support healing of deep cavity wounds healing by secondary intention, such as venous leg ulcers.. It is sterile: Yes, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Alginate dressing for exuding wounds** — To absorb heavy exudate and support healing of deep cavity wounds healing by secondary intention, such as venous leg ulcers..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12304
UMDNS Category: Dressings, Alginate
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Hydrofiber dressing for deep wounds". It does not go inside the body and is intended for to manage moderate to heavy exudate in partial- and full-thickness wounds, aiding secondary intention healing in deep ulcers or surgical dehiscence..
|
<think>
Analyzing the device: **Hydrofiber dressing for deep wounds** — To manage moderate to heavy exudate in partial- and full-thickness wounds, aiding secondary intention healing in deep ulcers or surgical dehiscence..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12312
UMDNS Category: Dressings, Hydrofiber
|
Thoroughly review the characteristics of this medical device. Apply all MDR classification rules, and determine the correct rule, indent, and risk class with clear justification.
|
I'm reviewing the device "Non-medicated hydrogel wound filler". It is used for to hydrate necrotic tissue and support autolysis in chronic wounds like pressure sores healing by secondary intent. and generally comes into contact with injured skin (breached dermis). The device is classified as non-invasive, not active, and sterile.
|
<think>
Analyzing the device: **Non-medicated hydrogel wound filler** — To hydrate necrotic tissue and support autolysis in chronic wounds like pressure sores healing by secondary intent..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12308
UMDNS Category: Dressings, Hydrogel
|
Given the device description below, walk through the MDR classification logic. Analyze each rule carefully and conclude with the appropriate classification.
|
The medical product named "Negative pressure wound therapy dressing kit" has the following use: To manage deep complex wounds by removing exudate and stimulating granulation tissue formation under negative pressure.. It touches Injured skin (deep wound) and is not implantable. It is active and is sterile.
|
<think>
Analyzing the device: **Negative pressure wound therapy dressing kit** — To manage deep complex wounds by removing exudate and stimulating granulation tissue formation under negative pressure..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 17699
UMDNS Category: Systems, Negative-Pressure Wound Therapy
|
Apply MDR Annex VIII to this device. Justify the final rule, indent, and risk class by examining and excluding each MDR rule in detail.
|
This device, "Collagen wound dressing", is described as to support the healing of full-thickness pressure ulcers and chronic wounds by providing a scaffold for cell proliferation.. It’s non-invasive, intended for prolonged use. Unsure if it is active or has software.
|
<think>
Analyzing the device: **Collagen wound dressing** — To support the healing of full-thickness pressure ulcers and chronic wounds by providing a scaffold for cell proliferation..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12303
UMDNS Category: Dressings, Collagen
Note: Some product attributes were estimated based on standard usage profiles.
|
Evaluate the following medical device as per MDR. Consider all possible classification rules and clearly explain why each rule applies or not before assigning the correct class.
|
Looking to classify "Foam dressing with border for pressure ulcers". Purpose: To provide cushioning and manage exudate in stage III/IV pressure ulcers that require secondary intention healing.. Contact type: Injured skin (breached dermis). Unsure of sterilization or measuring function.
|
<think>
Analyzing the device: **Foam dressing with border for pressure ulcers** — To provide cushioning and manage exudate in stage III/IV pressure ulcers that require secondary intention healing..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12302
UMDNS Category: Dressings, Foam
Note: Some product attributes were estimated based on standard usage profiles.
|
Classify this device according to MDR 2017/745. Interpret its features and rule out or confirm each MDR rule before giving the final classification.
|
A classification is requested for "Contact layer dressing for deep surgical wounds". It is typically non-invasive, not implantable, and used for to protect the wound bed and allow atraumatic dressing changes in post-debridement wounds healing by secondary intent..
|
<think>
Analyzing the device: **Contact layer dressing for deep surgical wounds** — To protect the wound bed and allow atraumatic dressing changes in post-debridement wounds healing by secondary intent..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12307
UMDNS Category: Dressings, Contact Layer
|
Perform a full MDR analysis of the device below. Use each rule to justify its exclusion or application, ending with a precise classification.
|
The device "Superabsorbent dressing for infected wounds" should be classified. It serves to to manage heavy exudate and reduce risk of maceration in chronic deep wounds that are infected and slow to heal., is non-invasive, and usually touches injured skin (breached dermis) surfaces.
|
<think>
Analyzing the device: **Superabsorbent dressing for infected wounds** — To manage heavy exudate and reduce risk of maceration in chronic deep wounds that are infected and slow to heal..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12311
UMDNS Category: Dressings, Superabsorbent
|
Based on the details provided, determine how this device is classified under MDR. Explain the applicability of each rule and give the final rule, indent, and risk class.
|
Hi! This product is "Multilayer wound dressing for tunneling wounds". It's not invasive or active, and doesn’t involve any tissue or drugs. Intended for: To fill, protect, and support the healing of cavity wounds or tunneling pressure ulcers healing by secondary intention..
|
<think>
Analyzing the device: **Multilayer wound dressing for tunneling wounds** — To fill, protect, and support the healing of cavity wounds or tunneling pressure ulcers healing by secondary intention..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIb
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12305
UMDNS Category: Dressings, Multilayer
|
Interpret this medical device through MDR classification rules. Make sure to assess each rule individually and justify its relevance or exclusion.
|
The following product, "Non-medicated hydrogel sheet dressing", is under evaluation. No known active function. It’s sterile: Yes, and software status is: No.
|
<think>
Analyzing the device: **Non-medicated hydrogel sheet dressing** — To maintain a moist wound environment and promote autolytic debridement for superficial or partial-thickness wounds..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12308
UMDNS Category: Dressings, Hydrogel
|
You are given a device for MDR classification. Use comprehensive reasoning for each rule to arrive at the right rule, indent, and class.
|
I need your help classifying "Transparent polymer film dressing". The product is used to to protect superficial wounds and provide a barrier to bacteria while allowing moisture vapor transmission.. It is sterile: Yes, active: No, invasive: Non-invasive.
|
<think>
Analyzing the device: **Transparent polymer film dressing** — To protect superficial wounds and provide a barrier to bacteria while allowing moisture vapor transmission..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12309
UMDNS Category: Dressings, Film
|
Apply medical device regulation MDR 2017/745. Step through every rule systematically, justify your reasoning, and finalize classification.
|
This device is known as "Foam dressing for superficial burns". It does not go inside the body and is intended for to maintain a moist healing environment and absorb exudate from superficial burn wounds without breaching the dermis..
|
<think>
Analyzing the device: **Foam dressing for superficial burns** — To maintain a moist healing environment and absorb exudate from superficial burn wounds without breaching the dermis..
Step-by-step review of all MDR rules to avoid misclassification:
**Rule 1**: Covers non-invasive devices with basic barrier or supportive function.
❌ Not applicable: The device does more than just act as a barrier.
**Rule 2**: Relates to devices that channel or store substances for eventual administration.
❌ Not applicable: It doesn't store, channel, or deliver substances.
**Rule 3**: Applies to modification of substances for infusion or delivery.
❌ Not applicable: It doesn't modify chemical/biological substances.
**Rule 4**: Covers devices in contact with injured skin or mucosa.
✔️ This rule applies because: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane
**Rule 5**: Short-term invasive via body orifice.
❌ Not applicable: It is not introduced into a body orifice.
**Rule 6**: Surgically invasive devices used transiently.
❌ Not applicable: It is not surgically invasive, even transiently.
**Rule 7**: Devices surgically invasive for short/long term.
❌ Not applicable: It is neither surgically invasive nor long-term.
**Rule 8**: Implantables or long-term invasive.
❌ Not applicable: It is not implantable nor invasive over long term.
**Rule 9**: Active therapeutic or diagnostic functions.
❌ Not applicable: No diagnostic or therapeutic active components.
**Rule 10**: Active devices for monitoring vital processes.
❌ Not applicable: No vital signs monitoring or active measurement.
**Rule 11**: Software-based classification.
❌ Not applicable: The product has no software component.
**Rule 12**: Energy exchange devices.
❌ Not applicable: No energy transmission or transformation occurs.
**Rule 13**: Reusable surgical instruments.
❌ Not applicable: It’s not a reusable surgical tool.
**Rule 14**: Contraceptive or fertility-related devices.
❌ Not applicable: This is not used for contraception or fertility.
**Rule 15**: Disinfectants for medical use.
❌ Not applicable: It’s not used to disinfect medical environments.
**Rule 16**: Sterilizers or disinfecting devices.
❌ Not applicable: It doesn’t sterilize or disinfect other devices.
**Rule 17**: Devices with animal origin tissue.
❌ Not applicable: It contains no animal-derived materials.
**Rule 18**: Human tissue-based devices.
❌ Not applicable: It contains no human-origin tissue.
**Rule 19**: Nanomaterial presence.
❌ Not applicable: It uses no nanomaterials in its composition.
**Rule 20**: Devices supporting logistics or traceability.
❌ Not applicable: Not a traceability/logistics support tool.
**Rule 21**: Devices with integral medicinal substance.
❌ Not applicable: No medicinal substance is present.
**Rule 22**: Custom-made/single-use invasive devices.
❌ Not applicable: It’s neither custom-made nor single-use invasive.
✅ Final decision: Rule Rule 4 applies — Devices that come into contact with injured skin or mucous membrane.
The device clearly matches the criteria of Rule Rule 4, as it all non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
— class i if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
— class iib if they are intended to be used principally for injuries to skin which have breached the dermis or
mucous membrane and can only heal by secondary intent;
— class iia if they are principally intended to manage the micro-environment of injured skin or mucous
membrane; and
— class iia in all other cases.
this rule applies also to the invasive devices that come into contact with injured mucous membrane
</think>
Risk Class: Class IIa
Applicable Rule: Rule Rule 4 – Devices that come into contact with injured skin or mucous membrane
Indent: General clause
Reason: All other rules have been explicitly reviewed and excluded. Rule Rule 4 fits based on device contact type, functionality, and intended use.
UMDNS Code: 12302
UMDNS Category: Dressings, Foam
|
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