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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
|
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