Rule number
string | Ruletitle
string | General explanation
string | Class
string | Rule
string | Examples
string | Practical Issues of classification
string |
|---|---|---|---|---|---|---|
Rule 1
|
Devices that either do not come in direct contact with the patient or contact intact skin only
|
This is a fall-back rule applying to all devices that are not covered by a more specific rule.
This is a rule that applies in general to devices that come into contact only with intact skin or that do not come in direct contact with the patient.
|
I (Klasse 1)
|
All non-invasive devices are classified as class I, unless one of the rules set out
hereinafter applies
|
- Devices intended in general for external patient support
(e.g. hospital beds, patient hoists, walking aids,
wheelchairs, stretchers, dental patient chairs)
- Body liquid collection devices intended to be used in such a
way that a return flow is unlikely (e.g. to collect body
wastes such as urine collection bottles, incontinence pads
or collectors used with wound drainage devices). They may
be connected to the patient by means of catheters and
Tubing
- Devices used to immobilise body parts and/or to apply force
or compression on them (e.g. non-sterile dressings used to
aid the healing of a sprain, plaster of Paris, cervical collars,
gravity traction devices, compression hosiery)
- Corrective spectacle frames (i.e. glasses) and lenses in
Frames
- Stethoscopes
- Eye occlusion plasters
- Incision drapes
- Non-invasive conductive gels i.e. ultrasound gels2
- Non-invasive electrodes (electrodes for EEG or ECG)
- Permanent magnets for removal of ocular debris
- Wheelchairs pushed by hand
|
Some non-invasive devices are indirectly in contact with the body and can influence internal physiological processes by storing, channelling or
treating blood, other body liquids or liquids which are returned or infused into the body or by generating energy that is delivered to the body.
These are handled by other rules because of the hazards inherent in such indirect influence on the body.
Note 1: Intact skin includes the skin around an established stoma unless the skin is breached. Signs of breached skin include, but not limited
to, tears, erythema, oedema, weeping and infection. The definition of intact skin must apply for the continuous use of the device.
Note 2: Ultrasound gels are not to be absorbed or locally dispersed within the body at the site of action in order to achieve their intended
Purpose.
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Rule 2
|
Channelling or storing for eventual administration
|
This rule applies to non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for specific
purposes. Invasive devices, other than surgically invasive devices which are intended to administer medicinal products by inhalation, fall under
the Rule 20
These types of devices should be considered separately from the non-contact devices of Rule 1 because they may be indirectly invasive. They
channel or store substances that will eventually be administered to the body. Typically these devices are used in transfusion, infusion,
extracorporeal circulation and delivery of anaesthetic gases and oxygen.
In some cases devices covered under this rule are very simple delivery devices that rely on gravity.
|
IIa (Klasse 2a)
|
All non-invasive devices intended for channeling 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 channeling or storing blood or other body liquids or for storing organs,
parts of organs or body cells and tissues,
|
- Devices intended to be used as channels in
active drug delivery systems, e.g. tubing
intended for use with an infusion pump
- Devices used for channelling gases, e.g.
antistatic tubing for anaesthesia, anaesthesia
breathing circuits
- Syringes for infusion pumps
- Devices intended to channel blood (e.g. in
transfusion, extracorporeal circulation)
- Devices intended for temporary storage and
transport of organs for transplantation (i.e.
containers, bags)
- Devices intended for long term storage of
biological substances and tissues such as
corneas, sperm, human embryos, etc. (i.e.
containers, bags)
- Fridges/freezers specifically intended for storing
blood, tissues etc.
- Tubings/blood lines for extracorporeal
treatment (dialysis and apheresis therapies)
|
If a device, e.g. tubing, intended to be used for a purpose that would require it to be connected to an active device, such a device will be
automatically in class IIa, unless the manufacturer clearly states that it should not be connected to an active device of class IIa or higher.
Note 1: ‘May be connected to an active device’ - such a connection is deemed to exist between a non-active device and an active device where
the non-active device forms a link in the transfer of the substance between the patient and the active device and the safety and performance
of one of the devices is influenced by the other device. For instance, this applies to tubing in an extracorporeal circulation system which is
downstream from a blood pump and in the same blood flow circuit, but not directly connected to the pump.
Note 2: See also Chapter 3.1.6 regarding the possible measuring function.
|
Rule 2
|
Channelling or storing for eventual administration
|
This rule applies to non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for specific
purposes. Invasive devices, other than surgically invasive devices which are intended to administer medicinal products by inhalation, fall under
the Rule 20
These types of devices should be considered separately from the non-contact devices of Rule 1 because they may be indirectly invasive. They
channel or store substances that will eventually be administered to the body. Typically these devices are used in transfusion, infusion,
extracorporeal circulation and delivery of anaesthetic gases and oxygen.
In some cases devices covered under this rule are very simple delivery devices that rely on gravity.
|
IIb (Klasse 2b)
|
- except for blood bags; blood bags are classified as class IIb.
|
- Blood bags without a substance which, if used
separately, can be considered to be a medicinal
product
|
If a device, e.g. tubing, intended to be used for a purpose that would require it to be connected to an active device, such a device will be
automatically in class IIa, unless the manufacturer clearly states that it should not be connected to an active device of class IIa or higher.
Note 1: ‘May be connected to an active device’ - such a connection is deemed to exist between a non-active device and an active device where
the non-active device forms a link in the transfer of the substance between the patient and the active device and the safety and performance
of one of the devices is influenced by the other device. For instance, this applies to tubing in an extracorporeal circulation system which is
downstream from a blood pump and in the same blood flow circuit, but not directly connected to the pump.
Note 2: See also Chapter 3.1.6 regarding the possible measuring function.
|
Rule 2
|
Channelling or storing for eventual administration
|
This rule applies to non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for specific
purposes. Invasive devices, other than surgically invasive devices which are intended to administer medicinal products by inhalation, fall under
the Rule 20
These types of devices should be considered separately from the non-contact devices of Rule 1 because they may be indirectly invasive. They
channel or store substances that will eventually be administered to the body. Typically these devices are used in transfusion, infusion,
extracorporeal circulation and delivery of anaesthetic gases and oxygen.
In some cases devices covered under this rule are very simple delivery devices that rely on gravity.
|
I (Klasse 1)
|
In all other cases, such devices are classified as class I
|
- Non-invasive devices that provide a simple
channelling function, with gravity providing the
force to transport the liquid, e.g. administration
sets for infusion
- Devices intended to be used for a temporary
containment or storage function, e.g. cups and
spoons specifically intended for administering
medicines2 Empty syringes without needles
|
If a device, e.g. tubing, intended to be used for a purpose that would require it to be connected to an active device, such a device will be
automatically in class IIa, unless the manufacturer clearly states that it should not be connected to an active device of class IIa or higher.
Note 1: ‘May be connected to an active device’ - such a connection is deemed to exist between a non-active device and an active device where
the non-active device forms a link in the transfer of the substance between the patient and the active device and the safety and performance
of one of the devices is influenced by the other device. For instance, this applies to tubing in an extracorporeal circulation system which is
downstream from a blood pump and in the same blood flow circuit, but not directly connected to the pump.
Note 2: See also Chapter 3.1.6 regarding the possible measuring function.
|
null | null | null | null | null | null | null |
Rule 3
|
Devices that modify biological or chemical composition of human tissues or cells, blood, other body
liquids or other liquids intended for implantation or administration into the body
|
These types of devices must be considered separately from the non-contact devices of Rule 1 because they are indirectly invasive. They modify
substances that will eventually be administered into the body. This rule covers mostly the more sophisticated elements of extracorporeal
circulation sets, dialysis systems and autotransfusion systems as well as devices for extracorporeal treatment of body fluids which may or may
not be immediately reintroduced into the body, including cases where the patient is not in a closed loop with the device.
This rule covers also substances in direct contact with human cells, tissues or organs in vitro before their implantation or administration, without
substances derived from human or animal origin such as human albumin.
|
IIb (Klasse 2b)
|
All non-invasive devices intended for modifying the biological or chemical composition of human
tissues or cells, blood, other body liquids or other liquids intended for implantation or
administration into the body are classified as class IIb,
|
- Devices intended to remove undesirable
substances out of the blood by exchange of
solutes such as hemodialysers
- Devices intended to separate cells by physical
means, e.g. gradient medium for sperm
separation
- Haemodialysis concentrates
- Device removing specific blood cells (e.g.
activated) by specific binding to a matrix
|
These devices are normally used in conjunction with an active medical device covered under Rule 9 or Rule 11.
Filtration and centrifugation should be understood in the context of this rule as being done exclusively through mechanical methods
|
Rule 3
|
Devices that modify biological or chemical composition of human tissues or cells, blood, other body
liquids or other liquids intended for implantation or administration into the body
|
These types of devices must be considered separately from the non-contact devices of Rule 1 because they are indirectly invasive. They modify
substances that will eventually be administered into the body. This rule covers mostly the more sophisticated elements of extracorporeal
circulation sets, dialysis systems and autotransfusion systems as well as devices for extracorporeal treatment of body fluids which may or may
not be immediately reintroduced into the body, including cases where the patient is not in a closed loop with the device.
This rule covers also substances in direct contact with human cells, tissues or organs in vitro before their implantation or administration, without
substances derived from human or animal origin such as human albumin.
|
IIa (Klasse 2a)
|
unless the treatment for which the device is used consists of filtration, centrifugation or
exchanges of gas, heat, in which case they are classified as class IIa
|
- Particulate filtration of blood in an
extracorporeal circulation system. These are
used to remove particles from the blood
- Centrifugation of blood to prepare it for
transfusion or autotransfusion excluding
centrifuges for manufacturing a medicinal
product
- Removal of carbon dioxide from the blood
and/or adding oxygen
- Warming or cooling the blood in an
extracorporeal circulation system.
|
These devices are normally used in conjunction with an active medical device covered under Rule 9 or Rule 11.
Filtration and centrifugation should be understood in the context of this rule as being done exclusively through mechanical methods
|
Rule 3
|
Devices that modify biological or chemical composition of human tissues or cells, blood, other body
liquids or other liquids intended for implantation or administration into the body
|
These types of devices must be considered separately from the non-contact devices of Rule 1 because they are indirectly invasive. They modify
substances that will eventually be administered into the body. This rule covers mostly the more sophisticated elements of extracorporeal
circulation sets, dialysis systems and autotransfusion systems as well as devices for extracorporeal treatment of body fluids which may or may
not be immediately reintroduced into the body, including cases where the patient is not in a closed loop with the device.
This rule covers also substances in direct contact with human cells, tissues or organs in vitro before their implantation or administration, without
substances derived from human or animal origin such as human albumin.
|
III (Klasse 3)
|
All non-invasive devices consisting of a substance or a mixture of substances intended to be
used in vitro in direct contact with human cells, tissues or organs taken from the human body
or used in vitro with human embryos before their implantation or administration into the body
are classified as class III.
|
- Substances or mixture of substances for
transport, perfusion, storage of organs intended
for transplantation that do not achieve the
principal intended action by pharmacological,
immunological or metabolic means
- IVF or ART products without principal
pharmacological/metabolic action (substances
or mixture of substances)
- IVF cell media without human albumin
|
These devices are normally used in conjunction with an active medical device covered under Rule 9 or Rule 11.
Filtration and centrifugation should be understood in the context of this rule as being done exclusively through mechanical methods
|
null | null | null | null | null | null | null |
Rule 4
|
Devices that come into contact with injured skin or mucous membrane
|
This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.
This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional
types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been
rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made,
e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.
More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or
epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a life-
sustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.
Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to
that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the
human body fall under Rule 21.
|
I (Klasse 1)
|
All non-invasive devices which come into contact with injured skin or mucous membrane are
classified as:
- class I if they are intended to be used as a mechanical barrier, for compression or for
absorption of exudates;
|
- Wound dressings for skin or mucous, such as:
absorbent pads, island dressings, cotton wool,
wound strips, adhesive bandages (sticking
plasters, band-aid) and gauze dressings which
act as a barrier, maintain wound position or
absorb exudates from the wound
- Ostomy bags
|
The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be
in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an
invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class
without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the
wound healing process usually implies that the device is at least class IIa.
Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical
barrier. Such devices are nevertheless classified according to their intended use in the higher class.
For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative,
or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively.
|
Rule 4
|
Devices that come into contact with injured skin or mucous membrane
|
This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.
This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional
types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been
rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made,
e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.
More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or
epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a life-
sustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.
Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to
that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the
human body fall under Rule 21.
|
IIb (Klasse 2b)
|
- class IIb if they are intended to be used principally for injuries to skin which have breached
the dermis or mucous membrane and can only heal by secondary intent;
|
Are principally intended to be used with severe
Wounds:
- Dressings intended for ulcerated wounds having
breached the dermis
- Dressings intended for burns having breached
the dermis
- Dressings for severe decubitus wounds
- Dressings incorporating means of augmenting
tissue and providing a temporary skin substitute
|
The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be
in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an
invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class
without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the
wound healing process usually implies that the device is at least class IIa.
Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical
barrier. Such devices are nevertheless classified according to their intended use in the higher class.
For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative,
or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively.
|
Rule 4
|
Devices that come into contact with injured skin or mucous membrane
|
This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.
This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional
types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been
rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made,
e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.
More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or
epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a life-
sustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.
Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to
that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the
human body fall under Rule 21.
|
IIa (Klasse 2a)
|
- class IIa if they are principally intended to manage the micro-environment of injured skin or
mucous membrane; and
|
- Hydrogel dressings for wounds or injuries that
have not breached the dermis or can only heal by
secondary intent
- Non-medicated impregnated gauze dressings
- Polymer film dressings
|
The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be
in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an
invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class
without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the
wound healing process usually implies that the device is at least class IIa.
Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical
barrier. Such devices are nevertheless classified according to their intended use in the higher class.
For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative,
or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively.
|
Rule 4
|
Devices that come into contact with injured skin or mucous membrane
|
This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.
This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional
types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been
rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made,
e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.
More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or
epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a life-
sustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.
Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to
that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the
human body fall under Rule 21.
|
IIa (Klasse 2a)
|
- class IIa in all other cases
| null |
The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be
in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an
invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class
without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the
wound healing process usually implies that the device is at least class IIa.
Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical
barrier. Such devices are nevertheless classified according to their intended use in the higher class.
For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative,
or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively.
|
Rule 4
|
Devices that come into contact with injured skin or mucous membrane
|
This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.
This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional
types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been
rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made,
e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.
More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or
epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a life-
sustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.
Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to
that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the
human body fall under Rule 21.
|
!
|
This rule applies also to the invasive devices that come into contact with injured mucous
Membrane.
|
- Dressings for nose bleeds (the purpose of the
dressing is not to manage micro-environment)
are in class I according to this rule
- Dental wound dressings not containing animal
derived material
|
The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be
in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an
invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class
without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the
wound healing process usually implies that the device is at least class IIa.
Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical
barrier. Such devices are nevertheless classified according to their intended use in the higher class.
For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative,
or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively.
|
null | null | null | null | null | null | null |
Rule 5
|
Devices invasive with respect to body orifices
|
Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
ophthalmology, dentistry, proctology, urology and gynaecology).
|
I (Klasse 1)
|
All invasive devices with respect to body orifices, other than surgically invasive devices,
which are not intended for connection to an active device or which are intended for
connection to a class I active device are classified as:
class I if they are intended for transient use;
|
- Handheld mirrors used in dentistry to aid in dental
diagnosis and surgery
- Dental impression materials
- Stomach tubes
- Impression trays
- Examination gloves
- Urinary catheters intended for transient use
- Embryo transfer catheter and insemination catheter
|
Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
instance a trachea cannula for long-term use need to be classified as class IIb.
Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21
|
Rule 5
|
Devices invasive with respect to body orifices
|
Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
ophthalmology, dentistry, proctology, urology and gynaecology).
|
IIa (Klasse 2a)
|
- class IIa if they are intended for short-term use,
|
- Short term corrective contact lenses
- Tracheal tubes
- Indwelling urinary catheters intended for short term
use
- Gasses used for insufflation in the body
- Nasobilliary tubes
|
Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
instance a trachea cannula for long-term use need to be classified as class IIb.
Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21
|
Rule 5
|
Devices invasive with respect to body orifices
|
Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
ophthalmology, dentistry, proctology, urology and gynaecology).
|
I (Klasse 1)
|
- except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the
ear drum or in the nasal cavity, in which case they are classified as class I; and
|
- Materials for dental impressions
- Plastic syringe used to measure a quantity of
medicinal product before oral administration to the
patient
- Removable or fixed dental prostheses
|
Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
instance a trachea cannula for long-term use need to be classified as class IIb.
Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21
|
Rule 5
|
Devices invasive with respect to body orifices
|
Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
ophthalmology, dentistry, proctology, urology and gynaecology).
|
IIb (Klasse 2b)
|
- class IIb if they are intended for long-term use.
|
- Urethral stents
- Long term corrective contact lenses
- Tracheal cannulae for tracheostoma for long term use
- Urinary catheters intended for long term use
|
Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
instance a trachea cannula for long-term use need to be classified as class IIb.
Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21
|
Rule 5
|
Devices invasive with respect to body orifices
|
Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
ophthalmology, dentistry, proctology, urology and gynaecology).
|
IIa (Klasse 2a)
|
- except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the
ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane,
in which case they are classified as class IIa.
|
- Orthodontic wires
- Fixed dental prostheses
- Fissure sealants
|
Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
instance a trachea cannula for long-term use need to be classified as class IIb.
Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21
|
Rule 5
|
Devices invasive with respect to body orifices
|
Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
ophthalmology, dentistry, proctology, urology and gynaecology).
|
IIa (Klasse 2a)
|
All invasive devices with respect to body orifices, other than surgically invasive devices,
intended for connection to a class IIa, class IIb or class III active device, are classified as
class IIa
|
- Tracheostomy or tracheal tubes connected to a
ventilator
- Blood oxygen analysers placed under the eye-lid
- Powered nasal irrigators
- Fibre optics in endoscopes connected to surgical lasers
- Suction catheters or tubes for stomach drainage
- Dental aspirator tips
- Endoscopes using a light source in the visible
spectrum
|
Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
instance a trachea cannula for long-term use need to be classified as class IIb.
Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21
|
null | null | null | null | null | null | null |
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
IIa (Klasse 2a)
|
All surgically invasive devices intended for transient use are classified as class IIa
unless they:
|
- Needles used for suturing
- Needles or syringes
- Lancets
- Single use scalpels and single use scalpel
blades
- Surgical swabs
- Surgical gloves
- Swabs to sample exudates
- Guidewires or catheters used outside the
central circulatory system
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
III (Klasse 3)
|
- are intended specifically to control, diagnose, monitor or correct a defect2 of the heart or of
the central circulatory system through direct contact with those parts of the body, in which
case they are classified as class III;
|
- Cardiovascular catheters (e.g. angioplasty
balloon catheters, stent delivery
catheters/systems), including related guidewires, related introducers and
dedicated disposable cardiovascular surgical
instruments e.g. electrophysiological
catheters, electrodes for electrophysiological
diagnosis and ablation,
- Catheters containing or incorporating sealed
radioisotopes, where the radioactive isotope is
not intended to be released into the body, if
used in the central circulatory system
- Distal protection devices
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
I (Klasse 1)
|
- are reusable surgical instruments, in which case they are classified as class I;
|
- Scalpels and scalpel handles
- Reamers
- Drill bits
- Saws, that are not intended for connection to
an active device
- Retractors forceps, excavators and chisels
- Sternum retractors for transient use
- Staplers (outside the heart, central circulatory
or central nervous system
- Dental Osteotomes
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
III (Klasse 3)
|
- are intended specifically for use in direct contact with the heart or central circulatory system
or the central nervous system, in which case they are classified as class III
|
- Neuro-endoscopes
- Brain spatulas
- Direct stimulation cannulae
- Spinal cord retractors
- Spinal needles
- Cranium guide for use in craniotomy
- Dura mater protection; Bone punch for use on
the cranium (Intended use: The dura mater
protection is intended to protect the dura
mater during surgical procedures. It has direct
contact to the CNS. The bone punch can be
used at the cranium. A direct contact to the
CNS is possible during application.)
- Peripherally inserted central catheter (PICC)
line
- Heart valve occluders, sizers and holders
- Cardiovascular drainage cannula specifically
intended to circulate blood whilst located in
the heart or central vascular system
- Cryo-ablation of the heart or spine
- Appliers/Forceps for aneurysm clips
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
IIb (Klasse 2b)
|
- are intended to supply energy in the form of ionising radiation in which case they are classified
as class IIb;
- or
|
- Catheters containing or incorporating sealed
radioisotopes, where the radioactive isotope
as such is not intended to be released into the
body, excluding the central circulatory system
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
IIb (Klasse 2b)
|
- have a biological effect or are wholly or mainly absorbed in which case they are classified as
class IIb;
|
- Viscoelastic solution for ophthalmic surgery
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
Rule 6
|
Surgically invasive devices intended for transient use (<60 min
|
This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.
|
IIb (Klasse 2b)
|
- are intended to administer medicinal products by means of a delivery system, if such
administration of a medicinal product is done in a manner that is potentially hazardous taking
account of the mode of application, in which case they are classified as class IIb.
|
- Refillable insulin pens
- Analgesia pumps
|
Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
surgical instruments’.
Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
that of a scalpel.
Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
of the heart or of the central circulatory system.
Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.
|
null | null | null | null | null | null | null |
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
IIa (Klasse 2a)
|
All surgically invasive devices intended for short-term use are classified as class IIa
unless they:
|
- Clamps
- Infusion cannulae
- Skin closure devices
- Temporary filling materials
- Arthroscopy trocars
- Insufflation gases for surgically invasive
endoscopic procedures
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
III (Klasse 3)
|
are intended specifically to control, diagnose, monitor or correct a defect of the heart or of
the central circulatory system through direct contact with those parts of the body, in which
case they are classified as class III;
|
- Cardiovascular catheters
- Cardiac output probes
- Temporary pacemaker leads
- Thoracic catheters intended to drain the heart,
including the pericardium
- Carotid artery shunts
- Ablation catheter
- Heart bypass cannula (aortic perfusion cannula
and venous drainage cannula)
- Peripherally inserted central catheter (PICC) line
and central line
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
III (Klasse 3)
|
are intended specifically for use in direct contact with the heart or central circulatory system
or the central nervous system, in which case they are classified as class III;
|
- Neurological catheters
- Cortical electrodes
- Central venous/vascular catheters
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
IIb (Klasse 2b)
|
are intended to supply energy in the form of ionizing radiation in which case they are
classified as class IIb;
|
- Brachytherapy devices
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
III (Klasse 3)
|
have a biological effect or are wholly or mainly absorbed in which case they are classified as
class III;
|
- Absorbable sutures
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
IIb (Klasse 2b)
|
are intended to undergo chemical change in the body in which case they are classified as
class IIb, except if the devices are placed in the teeth; or.
|
- Vascular closure devices
- Haemostatic foams
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
Rule 7
|
Surgically invasive devices intended for short-term use (> 60 min <30 days)
|
These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
and catheters of various types.
|
IIb (Klasse 2b)
|
are intended to administer medicines1, in which case they are classified as class IIb.
|
- Temporal dialysis catheter, CVVH catheter
|
Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
2001/83/EC or Regulation (EC) No 726/2004.
|
null | null | null | null | null | null | null |
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
IIb (Klasse 2b)
|
All implantable devices and long-term surgically invasive devices are classified as class IIb
unless they:
|
- Artificial ligaments for reinforcement2. Dental
implants and abutments
- Shunts
- Peripheral stents and peripheral valves
- Plates
- Intra-ocular lenses
- Internal closure devices (including vascular
closure devices1)
- Tissue augmentation implants (excluding
breasts)
- Peripheral vascular catheters for long-term use
- Peripheral vascular grafts and stents
- Penile implants
- Non-absorbable sutures, non-biodegreable bone
cements and maxillo-facial implants, visco-
elastic surgical devices intended specifically for
ophthalmic anterior segment surgery2
- Pedicle screws
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
IIa (Klasse 2a)
|
- are intended to be placed in the teeth3, in which case they are classified as class IIa;
|
- Bridges and crowns
- Dental filling materials and pins
- Dental alloys, ceramics and polymers
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- are intended to be used in direct contact with the heart, the central circulatory system or
the central nervous system, in which case they are classified as class III;
|
- Prosthetic heart valves
- Aneurysm clips
- Vascular prosthesis and stents
- Central vascular catheters for long-term use
- Spinal stents
- CNS electrodes
- Cardiovascular sutures
- Permanent and retrievable vena cava filters
- Septal occlusion devices
- Intra-aortic balloon pumps
- External left ventricular assisting devices
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- have a biological effect or are wholly or mainly absorbed, in which case they are classified
as class III;
|
- Long term absorbable sutures
- Adhesives and implantable devices claimed to be
bioactive through the attachment of surface
coatings such as phosphoryl choline
- Biodegrable Bone Cements
- Elastoviscus fluids for joint movement(eg.
hyaluronan of non-animal origin)
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- are intended to undergo chemical change4 in the body in which case they are classified as
class III, except if the devices are placed in the teeth
| null |
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- are intended to administer medicinal products, in which case they are classified as class III;
|
- Rechargeable non-active drug delivery systems
- Peritoneal dialysis
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
| null |
III (Klasse 3)
|
- are active implantable devices or their accessories, in which cases they are classified as
class III;
|
- Cochlear implants and accessories
Implantable cardiac pacemakers
- Implantable cardioverter defibrillators (ICD)
- Leads, electrodes, adaptors for pacemakers and
implantable defibrillators
- Implantable nerve stimulators
- Implantable bladder stimulators
- Implantable sphincter stimulators
- Accessories to active implantable devices (with
or without contact to the heart), be it
implantable or non-implantable active or not5:
-- torque wrench for implantable pulse
generator / implantable cardioverter
defibrillator
-- cables for programmer / pacing system
analyser
-- magnet for Implantable Pulse Generator /
Implantable Cardioverter Generator
-- programmer or an external transmitter
intended for activating or controlling the
implantable part of the device
-- implantable pacemaker leads
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- are breast implants or surgical meshes, in which cases they are classified as class III;
|
- Breast implants
- Breast tissue expanders
- Surgical meshes for hernia repair
- Tension free vaginal tape
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- are total or partial joint replacements, in which case they are classified as class III, with
the exception of ancillary components such as screws, wedges, plates and instruments;
or
|
- Hip, knee
- Shoulder
- Ankle
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
Rule 8
|
Implantable devices and long-term surgically invasive devices (> 30 days
|
These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
in plastic surgery.
|
III (Klasse 3)
|
- are spinal disc replacement implants or are implantable devices that come into contact with
the spinal column, in which case they are classified as class III with the exception of
components such as screws, wedges, plates and instruments
|
- Spinal disc replacement implants
- Spinal implants: hooks that fix the rod on the
spinal column
- Stems that are implantable in contact with the
spinal column
- Device placed in the disc space
- Interbody fusion devices
|
Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
procedure. Rule 18 may also be relevant.
Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
following the general rule.
Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
place during the placement and does not continue in long term.
Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.
|
null | null | null | null | null | null | null |
Rule 9
|
Active therapeutic devices intended to administer or exchange energy, as well as active devices
intended to control/monitor/directly influence certain devices
|
This rule covers many different groups of devices, such as:
- electrical equipment used in surgery such as lasers and surgical generators;
- stimulation devices;
- devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which
directly influence their performance;
- devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
Active implantable devices are covered by Rule 8.
Rule 22 may also apply to active therapeutic devices.
|
IIa (Klasse 2a)
|
All active therapeutic devices intended to administer or exchange energy are classified as
class IIa
|
- Electrical and/or magnetic and electromagnetic
Energy:
-- muscle stimulators
-- external bone growth stimulators
-- TENS devices
-- eye electromagnets
-- electrical acupuncture
- Thermal energy:
--heat exchangers, except the types described
below
- Mechanical energy:
--powered dermatomes
--powered drills
--dental hand pieces
- Light:
--phototherapy for skin treatment and for
neonatal care
- Sound:
--external hearing aids
- Ultrasound:
--equipment for physiotherapy
- Sleep apnoea ventilators without monitoring
function
|
Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous
way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and
the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management
(e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors
should be in Class IIb. However, the manufacturer's obligation to comply with design requirements and solutions adopted, exist independently
from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis
are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination
for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.
Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
|
Rule 9
|
Active therapeutic devices intended to administer or exchange energy, as well as active devices
intended to control/monitor/directly influence certain devices
|
This rule covers many different groups of devices, such as:
- electrical equipment used in surgery such as lasers and surgical generators;
- stimulation devices;
- devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which
directly influence their performance;
- devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
Active implantable devices are covered by Rule 8.
Rule 22 may also apply to active therapeutic devices.
|
IIb (Klasse 2b)
|
unless their characteristics are such that they may administer energy to or exchange energy
with the human body in a potentially hazardous way, taking account of the nature, the
density and site of application of the energy, in which case they are classified as class Iib.
|
- Kinetic energy:
lung ventilators
- Thermal energy:
--incubators for babies
--blood warmers
--electrically powered heat exchangers (with
patients incapable of reacting,
communicating /or who are without a sense
of feeling)
- Electrical energy:
-- high-frequency electrosurgical generators,
and electrocautery equipment, including their
electrodes
-- external pacemakers and external
defibrillators with no integrated or
incorporated diagnostic function
-- electroconvulsive therapy equipment
- Coherent light: surgical lasers
-Ultrasound: lithotriptors, surgical ultrasound devices, high-intensity focused ultrasound (HIFU
|
Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous
way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and
the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management
(e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors
should be in Class IIb. However, the manufacturer's obligation to comply with design requirements and solutions adopted, exist independently
from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis
are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination
for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.
Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
|
Rule 9
|
Active therapeutic devices intended to administer or exchange energy, as well as active devices
intended to control/monitor/directly influence certain devices
|
This rule covers many different groups of devices, such as:
- electrical equipment used in surgery such as lasers and surgical generators;
- stimulation devices;
- devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which
directly influence their performance;
- devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
Active implantable devices are covered by Rule 8.
Rule 22 may also apply to active therapeutic devices.
|
IIb (Klasse 2b)
|
All active devices intended to control or monitor the performance of active therapeutic class
IIb devices, or intended directly to influence the performance of such devices are classified
as class Iib.
|
- External feedback systems for active therapeutic
devices
|
Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous
way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and
the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management
(e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors
should be in Class IIb. However, the manufacturer's obligation to comply with design requirements and solutions adopted, exist independently
from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis
are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination
for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.
Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
|
Rule 9
|
Active therapeutic devices intended to administer or exchange energy, as well as active devices
intended to control/monitor/directly influence certain devices
|
This rule covers many different groups of devices, such as:
- electrical equipment used in surgery such as lasers and surgical generators;
- stimulation devices;
- devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which
directly influence their performance;
- devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
Active implantable devices are covered by Rule 8.
Rule 22 may also apply to active therapeutic devices.
|
IIb (Klasse 2b)
|
All active devices intended to emit ionizing radiation for therapeutic purposes, including
devices which control or monitor such devices, or which directly influence their performance,
are classified as class Iib
|
- Brachytherapy therapy devices if the device also
generates the radiation
- Therapeutic cyclotrons and linear accelerators
- Therapeutic X-ray sources
|
Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous
way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and
the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management
(e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors
should be in Class IIb. However, the manufacturer's obligation to comply with design requirements and solutions adopted, exist independently
from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis
are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination
for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.
Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
|
Rule 9
|
Active therapeutic devices intended to administer or exchange energy, as well as active devices
intended to control/monitor/directly influence certain devices
|
This rule covers many different groups of devices, such as:
- electrical equipment used in surgery such as lasers and surgical generators;
- stimulation devices;
- devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which
directly influence their performance;
- devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
Active implantable devices are covered by Rule 8.
Rule 22 may also apply to active therapeutic devices.
|
III (Klasse 3)
|
All active devices that are intended for controlling, monitoring or directly influencing the
performance of active implantable devices are classified as class III
|
- Programming units and pacing system analysers
- Cardioscopes with pacing pulse indicators
specifically intended to monitor active implantable
devices
- Programmer for:
-- implantable Pulse Generator (IPG);
-- implantable Cardioverter Defibrillator (ICD)
-- implantable Loop Recorder
- Remote monitoring devices for active implantable
devices
|
Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous
way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and
the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management
(e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors
should be in Class IIb. However, the manufacturer's obligation to comply with design requirements and solutions adopted, exist independently
from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis
are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination
for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.
Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
|
null | null | null | null | null | null | null |
Rule 10
|
Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
|
This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
implantable devices fall under Rule 8 or Rule 9.
|
IIa (Klasse 2a)
|
Active devices intended for diagnosis and monitoring are classified as class IIa:
- if they are intended to supply energy which will be absorbed by the human body,
|
- Magnetic resonance equipment
- Pulp testers
- Evoked response stimulators
- Diagnostic ultrasound
|
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
|
Rule 10
|
Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
|
This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
implantable devices fall under Rule 8 or Rule 9.
|
I (Klasse 1)
|
except for devices intended to illuminate1 the patient's body, in the visible spectrum, in which
case they are classified as class I;
|
- Examination lamps
- Surgical microscopes intended to illuminate the
patient’s body in the visible spectrum
- Dermatoscopes with integrated light sources
|
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
|
Rule 10
|
Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
|
This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
implantable devices fall under Rule 8 or Rule 9.
|
IIa (Klasse 2a)
|
- if they are intended to image in vivo distribution of radiopharmaceuticals; or
|
- Gamma cameras
- Positron emission tomography and single
photon emission computer tomography
|
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
|
Rule 10
|
Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
|
This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
implantable devices fall under Rule 8 or Rule 9.
|
IIa (Klasse 2a)
|
- if they are intended to allow direct diagnosis2 or monitoring of vital physiological processes
|
- Electrocardiographs
- Electroencephalographs
- Electronic thermometers
- Electronic stethoscopes
- Electronic blood pressure measuring equipment
|
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
|
Rule 10
|
Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
|
This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
implantable devices fall under Rule 8 or Rule 9.
|
IIb (Klasse 2b)
|
unless they are specifically intended for monitoring of vital physiological parameters and the
nature of variations of those parameters is such that it could result in immediate danger to
the patient, for instance variations in cardiac performance, respiration, activity of the central
nervous system, or they are intended for diagnosis in clinical situations where the patient is
in immediate danger, in which cases they are classified as class IIb.
|
- Blood gas analysers used in open heart surgery
- Apnoea monitors, including apnoea monitors in
home care
- Patient monitors (intended use: Monitor
intended for multi-parameter patient
monitoring. The device will produce visual and
audible alarms if any of the physiological
parameters monitored vary beyond pre-set
limits and timed alarm recordings will be
produced.), for example in intensive care
monitoring, e.g. blood pressure, temperature,
oxygen saturation
|
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
|
Rule 10
|
Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
|
This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
implantable devices fall under Rule 8 or Rule 9.
|
IIb (Klasse 2b)
|
Active devices intended to emit ionizing radiation4 and intended for diagnostic or
therapeutic radiology, including interventional radiology devices and devices which
control or monitor such devices, or which directly influence their performance, are
classified as class IIb.
|
- Diagnostic X-Ray machine
- Computed Tomography Devices
|
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
|
null | null | null | null | null | null | null |
Rule 11
|
Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
|
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).
Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or
to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an
accessory.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not
be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses
Etc.
|
IIa (Klasse 2a)
|
Software intended to provide information which is used to take decisions with diagnosis or
therapeutic purposes is classified as class IIa,
except if such decisions have an impact that may cause:
|
- MDSW intended to rank therapeutic suggestions
for a health care professional based on patient
history, imaging test results, and patient
characteristics, for example, MDSW that lists
and ranks all available chemotherapy options for
BRCA-positive individuals.
- Cognitive therapy MDSW where a specialist
determines the necessary cognitive therapy
based on the outcome provided by the MDSW.
|
Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the
vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .
Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be
treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by
the software as well as of the possible decisions to be taken.
Note 3: Medical device software should be classified in the same way, regardless of the software's location or the type of interconnection
between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a
device or influences the use of a device shall fall within the same class as the device.
For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software -
Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
Rule 11
|
Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
|
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).
Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or
to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an
accessory.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not
be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses
Etc.
|
III (Klasse 3)
|
— death or an irreversible deterioration of a person's state of health1, in which case it is in
class III; or
|
- MDSW intended to perform diagnosis by means
of image analysis for making treatment
decisions in patients with acute stroke.
|
Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the
vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .
Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be
treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by
the software as well as of the possible decisions to be taken.
Note 3: Medical device software should be classified in the same way, regardless of the software's location or the type of interconnection
between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a
device or influences the use of a device shall fall within the same class as the device.
For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software -
Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
Rule 11
|
Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
|
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).
Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or
to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an
accessory.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not
be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses
Etc.
|
IIb (Klasse 2b)
|
— a serious deterioration of a person's state of health1 or a surgical intervention, in which case
it is classified as class Iib.
|
- A mobile app intended to analyse a user’s
heartbeat, detect abnormalities and inform a
physician accordingly.
MDSW intended for diagnosing depression based
on a score resulting from inputted data on
patient symptoms (e.g. anxiety, sleep patterns,
stress etc.).
|
Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the
vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .
Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be
treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by
the software as well as of the possible decisions to be taken.
Note 3: Medical device software should be classified in the same way, regardless of the software's location or the type of interconnection
between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a
device or influences the use of a device shall fall within the same class as the device.
For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software -
Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
Rule 11
|
Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
|
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).
Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or
to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an
accessory.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not
be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses
Etc.
|
IIa (Klasse 2a)
|
Software intended to monitor physiological processes is classified as class Iia,
|
- MDSW intended to monitor physiological
processes that are not considered to be vital.
- Devices intended to be used to obtain readings
of vital physiological signals in routine check-ups
including monitoring at home.
|
Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the
vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .
Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be
treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by
the software as well as of the possible decisions to be taken.
Note 3: Medical device software should be classified in the same way, regardless of the software's location or the type of interconnection
between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a
device or influences the use of a device shall fall within the same class as the device.
For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software -
Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
Rule 11
|
Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
|
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).
Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or
to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an
accessory.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not
be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses
Etc.
|
IIb (Klasse 2b)
|
except if it is intended for monitoring of vital physiological parameters3, where the nature of
variations of those parameters is such that it could result in immediate danger to the patient,
in which case it is classified as class Iib.
|
- Medical devices including MDSW intended to be
used for continuous surveillance of vital
physiological processes in anaesthesia, intensive
care or emergency care.
|
Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the
vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .
Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be
treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by
the software as well as of the possible decisions to be taken.
Note 3: Medical device software should be classified in the same way, regardless of the software's location or the type of interconnection
between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a
device or influences the use of a device shall fall within the same class as the device.
For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software -
Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
Rule 11
|
Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
|
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).
Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or
to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an
accessory.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not
be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses
Etc.
|
I (Klasse 1)
|
All other software is classified as class I.
|
- MDSW app intended to support conception by
calculating the user’s fertility status based on a
validated statistical algorithm. The user inputs
health data including basal body temperature (BBT) and menstruation days to track and
predict ovulation. The fertility status of the
current day is reflected by one of three indicator
lights: red (fertile), green (infertile) or yellow
(learning phase/cycle fluctuation).
|
Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the
vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .
Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be
treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by
the software as well as of the possible decisions to be taken.
Note 3: Medical device software should be classified in the same way, regardless of the software's location or the type of interconnection
between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a
device or influences the use of a device shall fall within the same class as the device.
For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software -
Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
null | null | null | null | null | null | null |
Rule 12
|
Active devices intended to administer and/or remove medicinal products, body liquids or other
substances to or from the body
|
This rule is intended to primarily cover drug delivery systems and anaesthesia equipment. If the device’s intended route of drug delivery is
pulmonary, Rule 20 applies.
|
IIa (Klasse 2a)
|
All active devices intended to administer and/or remove medicinal products, body liquids or
other substances to or from the body are classified as class Iia,
|
- Suction pump
- Feeding pumps
- Jet injectors for vaccination
- Elastomeric pumps or balloon pumps for infusion
| null |
Rule 12
|
Active devices intended to administer and/or remove medicinal products, body liquids or other
substances to or from the body
|
This rule is intended to primarily cover drug delivery systems and anaesthesia equipment. If the device’s intended route of drug delivery is
pulmonary, Rule 20 applies.
|
IIb (Klasse 2b)
|
unless this is done in a manner that is potentially hazardous, taking account of the nature of
the substances involved, of the part of the body concerned and of the mode of application in
which case they are classified as class Iib.
|
- Infusion pumps
- Ventilators
- Anaesthesia machines
- Anaesthetic vaporisers
- Dialysis equipment
- Blood pumps for heart-lung machines
- Hyperbaric chambers
- Pressure regulators for medical gases
- Medical gas mixers
- Moisture exchangers in breathing circuits if used
on unconscious or non-spontaneously breathing
patients
- Oxygen concentrator used to deliver oxygen
enriched air directly to the patient
| null |
null | null | null | null | null | null | null |
Rule 13
|
All other active devices
|
This is a fallback rule to cover all active devices not covered by other rules.
|
I (Klasse 1)
|
All other active devices are classified as class I.
|
- Electric wheelchairs
- Dental curing lights
- Electric hospital beds
- Patient hoists
- Dental patient chairs
| null |
null | null | null | null | null | null | null |
Rule 14
|
Devices incorporating, as an integral part, an ancillary medicinal product, and medicinal products
derived from human blood or blood plasma
|
This rule covers those devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product,
with an action ancillary to that of the device. The principal intended action of the device must not be achieved through a pharmacological,
immunological or metabolic action of the incorporated medicinal substance1. If the principal intended action of the device is mainly achieved by
the action of the medicinal substance, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the
European Parliament and of the Council, as applicable. For more information see the MDCG Guidance document covering the borderline between
medical devices and medicinal products. The same principle applies if a substance of animal origin, as defined in Art. 2(17), is part of the device
and has an action ancillary to that of a device.
|
III (Klasse 3)
|
All devices incorporating, as an integral part, a substance which, if used separately, can be
considered to be a medicinal product, as defined in point 2 of Article 1 of Directive
2001/83/EC, including a medicinal product derived from human blood or human plasma, as
defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the
devices, are classified as class III.
|
- Bone cement with antibiotics
- Condoms with spermicide
- Catheters coated with anticoagulants (e. g. heparin)
- Endodontic materials with antibiotics
- Ophthalmic irrigation solutions principally
intended for irrigation, which contain
components supporting the metabolism of the
endothelial cells of the cornea
- Dressings incorporating an antimicrobial agent
where the agent has an ancillary action on the
wound
- Drug eluting stents (e.g. coronary, pulmonary)
- Surgical sealants containing human serum
albumin or thrombin
- Implants coated with human fibrinogen
- Blood bags incorporating heparin or other
substances as anticoagulant agents which, if
used separately, can be considered to be a
medicinal product
- IVF cell media with human albumin2
- Intra Uterine Devices (IUD) containing medicinal
substances3 including copper or silver
- Catheter lubrication gels containing analgesia
e.g. lidocaine
|
Note 1: The definition of ‘substance’ in Article 1 (3) of Directive 2001/83/EC is applicable as far as not excluded by the MDR (e. g. exclusion
criteria Article 1 (6) (h)).
Note 2: IVF cell media with human albumin are in class III according to Rule 14 and Rule 3. (Rule 14 applies, being the strictest, according
to MDR, Annex VIII, chapter II, point 3.5.)
Note 3: This only applies if the effect of the medicinal substance is ancillary – if it is the main effect, the IUD would be classified as a medicinal
product
N.B.: For the clarification of the meaning and application of ‘a substance which, if used separately, can be considered to be a medicinal product’
and of ‘has an action ancillary to that of the device’, clarification which is relevant for the application of this rule, see clarification provided in
the respective section of the MDCG Guidance document covering the borderline between medical devices and medicinal products
|
null | null | null | null | null | null | null |
Rule 15
|
Devices used for contraception or prevention of sexually transmitted diseases
|
This rule covers invasive, implantable and non-invasive medical devices for contraception or prevention of sexually transmitted diseases, i.e.
this rule is not limited to devices based on physical barriers. The rule covers contraception devices and devices used in prevention of transmission
of sexually transmitted diseases, where non-invasive, devices for transient or short term use are of class IIb and long-term use or implantable
devices are of class III.
Devices for fertility monitoring or testing to facilitate conception (and not used in contraception) are not covered by this rule.
Some devices may have dual functions, intended to be used both for contraception and prevention of the transmission of sexually transmitted
diseases, e.g. condoms.
|
IIb (Klasse 2b)
|
All devices used for contraception or prevention of the transmission of sexually transmitted
diseases are classified as class Iib,
|
- Condoms and femidoms (internal condoms)
- Contraceptive diaphragms
- Fertility monitors and medical device software
intended to be used in contraception (e.g. by
using the basal body temperature)
| null |
Rule 15
|
Devices used for contraception or prevention of sexually transmitted diseases
|
This rule covers invasive, implantable and non-invasive medical devices for contraception or prevention of sexually transmitted diseases, i.e.
this rule is not limited to devices based on physical barriers. The rule covers contraception devices and devices used in prevention of transmission
of sexually transmitted diseases, where non-invasive, devices for transient or short term use are of class IIb and long-term use or implantable
devices are of class III.
Devices for fertility monitoring or testing to facilitate conception (and not used in contraception) are not covered by this rule.
Some devices may have dual functions, intended to be used both for contraception and prevention of the transmission of sexually transmitted
diseases, e.g. condoms.
|
III (Klasse 3)
|
unless they are implantable or long term invasive devices, in which case they are classified as
class III.
|
- Tubal ligation devices (e.g. clips or rings)
- Non-hormonal intrauterine contraceptive
devices (IUCD or ICD)
| null |
null | null | null | null | null | null | null |
Rule 16
|
Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices
|
This rule is intended to cover various products used specifically with contact lenses such as solutions intended for storing contact lenses and
solutions used to support contact lenses placed on the ocular surface.
The rule also covers substances and equipment specifically intended for the disinfection or sterilisation of devices intended by the manufacturer
to be sterilised or disinfected prior to use, as referred to in MDR Article 2(1).
This rule does not apply to physical means for the cleaning of medical devices, such as ultrasound and brushes for general use. Such products
will only be medical devices if they are specifically intended for the cleaning, disinfection or sterilisation of medical devices. Devices specifically
intended for physical cleaning of contact lenses are covered by this rule
|
IIb (Klasse 2b)
|
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where
appropriate, hydrating contact lenses are classified as class Iib.
|
- Contact lens storing solutions
- Cleaners for contact lenses
- Ultraviolet, vibration, or ultrasonic devices for
cleaning and disinfecting contact lenses
|
Note 1: Including disinfecting solutions or washer-disinfectors that require no further processing for a disinfected device ready to be used. The
rule also covers devices where the intended use is to disinfect prion contaminations
|
Rule 16
|
Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices
|
This rule is intended to cover various products used specifically with contact lenses such as solutions intended for storing contact lenses and
solutions used to support contact lenses placed on the ocular surface.
The rule also covers substances and equipment specifically intended for the disinfection or sterilisation of devices intended by the manufacturer
to be sterilised or disinfected prior to use, as referred to in MDR Article 2(1).
This rule does not apply to physical means for the cleaning of medical devices, such as ultrasound and brushes for general use. Such products
will only be medical devices if they are specifically intended for the cleaning, disinfection or sterilisation of medical devices. Devices specifically
intended for physical cleaning of contact lenses are covered by this rule
|
IIa (Klasse 2a)
|
All devices intended specifically to be used for disinfecting or sterilising medical devices are
classified as class Iia,
|
- Disinfecting solutions specifically intended for
non-invasive medical devices
- Washer-disinfectors intended specifically for
disinfecting non-invasive medical devices
- Sterilisers intended to sterilise medical devices in
a medical environment
|
Note 1: Including disinfecting solutions or washer-disinfectors that require no further processing for a disinfected device ready to be used. The
rule also covers devices where the intended use is to disinfect prion contaminations
|
Rule 16
|
Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices
|
This rule is intended to cover various products used specifically with contact lenses such as solutions intended for storing contact lenses and
solutions used to support contact lenses placed on the ocular surface.
The rule also covers substances and equipment specifically intended for the disinfection or sterilisation of devices intended by the manufacturer
to be sterilised or disinfected prior to use, as referred to in MDR Article 2(1).
This rule does not apply to physical means for the cleaning of medical devices, such as ultrasound and brushes for general use. Such products
will only be medical devices if they are specifically intended for the cleaning, disinfection or sterilisation of medical devices. Devices specifically
intended for physical cleaning of contact lenses are covered by this rule
|
IIb (Klasse 2b)
|
unless they are disinfecting solutions or washer-disinfectors intended specifically to be used
for disinfecting invasive devices, as the end point of processing1, in which case they are
classified as class Iib.
|
- Solutions/disinfectors for trans oesophageal
ultrasound probes)
- Washer-disinfector equipment specifically for
disinfecting endoscopes or other invasive devices
at the end point of processing (e. g. dental
equipment)
- Disinfectants for the fluid pathways of
haemodialysis equipment
- Denture disinfecting products
|
Note 1: Including disinfecting solutions or washer-disinfectors that require no further processing for a disinfected device ready to be used. The
rule also covers devices where the intended use is to disinfect prion contaminations
|
Rule 16
|
Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices
|
This rule is intended to cover various products used specifically with contact lenses such as solutions intended for storing contact lenses and
solutions used to support contact lenses placed on the ocular surface.
The rule also covers substances and equipment specifically intended for the disinfection or sterilisation of devices intended by the manufacturer
to be sterilised or disinfected prior to use, as referred to in MDR Article 2(1).
This rule does not apply to physical means for the cleaning of medical devices, such as ultrasound and brushes for general use. Such products
will only be medical devices if they are specifically intended for the cleaning, disinfection or sterilisation of medical devices. Devices specifically
intended for physical cleaning of contact lenses are covered by this rule
|
!
|
This rule does not apply to devices that are intended to clean devices other than contact
lenses by means of physical action only.
|
- Brushes specifically intended to clean medical
devices by mechanical action
- Ultrasonic devices (for other devices than contact
lenses)
|
Note 1: Including disinfecting solutions or washer-disinfectors that require no further processing for a disinfected device ready to be used. The
rule also covers devices where the intended use is to disinfect prion contaminations
|
null | null | null | null | null | null | null |
Rule 17
|
Devices to record X-ray diagnostic images
|
This rule covers stand-alone X-ray detectors and sensors as recording devices used in several types or modalities of medical imaging procedures,
each of which uses different technologies and techniques. It covers non-active devices and active devices used to record X-ray diagnostic images
of the human body. The intention of the rule is to cover primarily digital devices and analogous recording media, but not media (including digital
media) used for subsequent image processing and storage
|
IIa (Klasse 2a)
|
Devices specifically intended for recording of diagnostic images generated by X-ray radiation
are classified as class Iia.
|
- Digital x-ray detectors for recording images
- Photostimulable phosphor plates
- X-ray films
|
Note 1: Devices intended to emit ionizing radiation for diagnostic and or therapeutic purposes are not covered by this rule. See Rule 10.
|
null | null | null | null | null | null | null |
Rule 18
|
Devices manufactured utilizing tissue or cells of human or animal origin or their derivatives
|
This rule covers devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered
non-viable, i.e. where there is no longer any capacity for cellular metabolic activity. This includes devices containing derivatives of human origin
that have an ancillary action to that of the device, as well as devices that contain or are made of animal tissues (non-derivative) that have been
rendered non-viable, or their derivatives.
|
III (Klasse 3)
|
All devices manufactured utilising tissues or cells of human or animal origin, or their
derivatives1, which are non- viable or rendered non-viable, are classified as class III,
|
- Animal derived biological heart valves
- Porcine xenograft dressings
- Devices made from animal sourced
collagen/gelatine
- Devices utilising hyaluronic acid of animal origin
- Substance-based devices containing collagen
for use in body orifices
- Collagen dermal fillers
- Bone graft substitutes
|
Note 1: Derivatives are products that are processed from animal tissues and excludes products made by animals e.g. milk, silk, beeswax,
honey, propolis, royal jelly, hair, lanolin.
Note 2: The industrial manufacturing process for some devices may employ raw materials which contain small amounts of tallow or tallow
derivatives (e.g. stearates in polymers) for example for greasing the moulds. Such substances, which may be present in the final device only
as trace amounts, are not considered as derivatives of animal tissues for the purpose of this rule which therefore does not apply. However, if
such substances are a constituent part of a device the rule will apply, for example wound dressings impregnated with tallow. Such an exemption
applies only to classification, and not to other obligations related to devices manufactured utilising non-viable substances of animal origin, such
as those referred to in Annex I 13.2.
Note 3: This rule does not apply to devices manufactured utilizing tissues or cells of animal origin or their derivatives coming into contact with
intact skin only. In such cases they are in class I in accordance to Rule 1. Intact skin includes the skin around an established stoma unless the
skin is breached.
|
Rule 18
|
Devices manufactured utilizing tissue or cells of human or animal origin or their derivatives
|
This rule covers devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered
non-viable, i.e. where there is no longer any capacity for cellular metabolic activity. This includes devices containing derivatives of human origin
that have an ancillary action to that of the device, as well as devices that contain or are made of animal tissues (non-derivative) that have been
rendered non-viable, or their derivatives.
|
I (Klasse 1)
|
unless such devices are manufactured utilising tissues or cells of animal origin, or their
derivatives, which are non-viable or rendered non-viable and are devices intended to come
into contact with intact skin only.
|
- Leather components of orthopaedic appliances
|
Note 1: Derivatives are products that are processed from animal tissues and excludes products made by animals e.g. milk, silk, beeswax,
honey, propolis, royal jelly, hair, lanolin.
Note 2: The industrial manufacturing process for some devices may employ raw materials which contain small amounts of tallow or tallow
derivatives (e.g. stearates in polymers) for example for greasing the moulds. Such substances, which may be present in the final device only
as trace amounts, are not considered as derivatives of animal tissues for the purpose of this rule which therefore does not apply. However, if
such substances are a constituent part of a device the rule will apply, for example wound dressings impregnated with tallow. Such an exemption
applies only to classification, and not to other obligations related to devices manufactured utilising non-viable substances of animal origin, such
as those referred to in Annex I 13.2.
Note 3: This rule does not apply to devices manufactured utilizing tissues or cells of animal origin or their derivatives coming into contact with
intact skin only. In such cases they are in class I in accordance to Rule 1. Intact skin includes the skin around an established stoma unless the
skin is breached.
|
null | null | null | null | null | null | null |
Rule 19
|
Devices incorporating or consisting of nanomaterial
|
The concept of internal exposure is a key element for the classification incorporating or consisting of nanomaterials. In its ‘Opinion on the
Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’30, the Scientific Committee on Emerging
and Newly Identified Health Risks (SCENIHR) states as a conclusion, that the potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure. Table 3 of the SCENIHR
Opinion estimates both external and internal exposure based on the type of device, type of application, type (location) of contact, and duration
of contact. As indicated in the explanation of table 3 of the SCENIHR opinion, the ‘potential internal systemic exposure of all organ systems’ is
what is listed, which can be expected to occur after release of free nanoparticles from invasive devices as well as from non-invasive devices in
contact with a breached or compromised body surface. This Table 3 uses the terms high/medium/low/negligible, as also used in the classification
rule. This Table 3 could be used as a starting point for correct classification. This Table 3 indicates a value for potential contact and/or external
exposure to the nanomaterial and potential internal systemic exposure of all organ systems However, every individual device needs to be
classified taking into account its own specific characteristics with regard to the potential release of free nanoparticles taking also into account
the exposure by the same nanomaterial via daily exposure routes., Also factors such as the number of nanomaterials in or on the product and
the amount of product applied in the intended use have been taken into account. This Table 3 indicates a value for potential contact and/or
external exposure to the nanomaterial and potential internal systemic exposure of all organ systems.
| null |
All devices incorporating or consisting of nanomaterial are classified as
| null |
Note 1: The high, medium, low or negligible potential of internal exposure is based on the combination of different factors such as the application
site of a medical device, type of contact (e.g. tissue, cells or body fluids), contact time and the type of incorporation of the nanomaterial(s)
(free, fixed, embedded). When the nanomaterial is applied as coating on the surface of the device, it is important to consider the type of
interaction with the material (chemisorption versus physisorption). When the nanomaterial is embedded in a matrix it will be important to
consider the degradability of the material.
Note 2: Internal exposure: exposure may occur via injured skin or mucous membrane, (surgically) invasive devices and implantable devices.
Note 3: Dental materials which are placed in the patient’s teeth in a paste form, where they are cured to a solid form, may release nanomaterials
during a very short exposure time. For most of the exposure time, these devices contain firmly bound nanomaterials. In many cases, grinding
and/or polishing takes place during the application of the device, and could also lead to exposure to nanomaterials. Such nanomaterials do not
necessarily contain the original nanomaterials present in the paste formulation. It is very important to include this aspect in the risk assessment
of such devices. For classification purposes the potential internal exposure to nanomaterials from these devices can generally be considered
negligible. Classification of this kind of materials should be based on the first state, in this example, the short exposure to the paste form which
has higher potential for release than the cured material.
Note 4: Devices with components incorporating nanomaterials that have no intended direct or indirect contact with users or patients, such as
the tires of wheelchairs or walking frames made from rubber reinforced with carbon black nanomaterials, should be exempt from classification
under Rule 19.
Note 5: Medical devices not incorporating or consisting of nanomaterials can still present a potential for internal exposure to nanomaterials due
to degradation or wear processes. While it is very important to include this aspect in the risk assessment of such devices, it is not a factor to
be considered when deciding the classification under Rule 19 since this rule is only applicable for medical devices incorporating or consisting of
Nanomaterials.
|
Rule 19
|
Devices incorporating or consisting of nanomaterial
|
The concept of internal exposure is a key element for the classification incorporating or consisting of nanomaterials. In its ‘Opinion on the
Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’30, the Scientific Committee on Emerging
and Newly Identified Health Risks (SCENIHR) states as a conclusion, that the potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure. Table 3 of the SCENIHR
Opinion estimates both external and internal exposure based on the type of device, type of application, type (location) of contact, and duration
of contact. As indicated in the explanation of table 3 of the SCENIHR opinion, the ‘potential internal systemic exposure of all organ systems’ is
what is listed, which can be expected to occur after release of free nanoparticles from invasive devices as well as from non-invasive devices in
contact with a breached or compromised body surface. This Table 3 uses the terms high/medium/low/negligible, as also used in the classification
rule. This Table 3 could be used as a starting point for correct classification. This Table 3 indicates a value for potential contact and/or external
exposure to the nanomaterial and potential internal systemic exposure of all organ systems However, every individual device needs to be
classified taking into account its own specific characteristics with regard to the potential release of free nanoparticles taking also into account
the exposure by the same nanomaterial via daily exposure routes., Also factors such as the number of nanomaterials in or on the product and
the amount of product applied in the intended use have been taken into account. This Table 3 indicates a value for potential contact and/or
external exposure to the nanomaterial and potential internal systemic exposure of all organ systems.
|
III (Klasse 3)
|
—class III if they present a high or medium potential for internal exposure
|
- Bone fillers with nanomaterials in their formulation (not
polymerized before blood/tissue contact, and degradable)
- Superparamagnetic iron oxide nanoparticles
(Intended use: thermal ablation of tumors or thermal modulation
of the tumor microenvironment by submission to alternating
magnetic fields)
- Intravascular catheter made of non-degradable polymer, with
nano-coating
|
Note 1: The high, medium, low or negligible potential of internal exposure is based on the combination of different factors such as the application
site of a medical device, type of contact (e.g. tissue, cells or body fluids), contact time and the type of incorporation of the nanomaterial(s)
(free, fixed, embedded). When the nanomaterial is applied as coating on the surface of the device, it is important to consider the type of
interaction with the material (chemisorption versus physisorption). When the nanomaterial is embedded in a matrix it will be important to
consider the degradability of the material.
Note 2: Internal exposure: exposure may occur via injured skin or mucous membrane, (surgically) invasive devices and implantable devices.
Note 3: Dental materials which are placed in the patient’s teeth in a paste form, where they are cured to a solid form, may release nanomaterials
during a very short exposure time. For most of the exposure time, these devices contain firmly bound nanomaterials. In many cases, grinding
and/or polishing takes place during the application of the device, and could also lead to exposure to nanomaterials. Such nanomaterials do not
necessarily contain the original nanomaterials present in the paste formulation. It is very important to include this aspect in the risk assessment
of such devices. For classification purposes the potential internal exposure to nanomaterials from these devices can generally be considered
negligible. Classification of this kind of materials should be based on the first state, in this example, the short exposure to the paste form which
has higher potential for release than the cured material.
Note 4: Devices with components incorporating nanomaterials that have no intended direct or indirect contact with users or patients, such as
the tires of wheelchairs or walking frames made from rubber reinforced with carbon black nanomaterials, should be exempt from classification
under Rule 19.
Note 5: Medical devices not incorporating or consisting of nanomaterials can still present a potential for internal exposure to nanomaterials due
to degradation or wear processes. While it is very important to include this aspect in the risk assessment of such devices, it is not a factor to
be considered when deciding the classification under Rule 19 since this rule is only applicable for medical devices incorporating or consisting of
Nanomaterials.
|
Rule 19
|
Devices incorporating or consisting of nanomaterial
|
The concept of internal exposure is a key element for the classification incorporating or consisting of nanomaterials. In its ‘Opinion on the
Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’30, the Scientific Committee on Emerging
and Newly Identified Health Risks (SCENIHR) states as a conclusion, that the potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure. Table 3 of the SCENIHR
Opinion estimates both external and internal exposure based on the type of device, type of application, type (location) of contact, and duration
of contact. As indicated in the explanation of table 3 of the SCENIHR opinion, the ‘potential internal systemic exposure of all organ systems’ is
what is listed, which can be expected to occur after release of free nanoparticles from invasive devices as well as from non-invasive devices in
contact with a breached or compromised body surface. This Table 3 uses the terms high/medium/low/negligible, as also used in the classification
rule. This Table 3 could be used as a starting point for correct classification. This Table 3 indicates a value for potential contact and/or external
exposure to the nanomaterial and potential internal systemic exposure of all organ systems However, every individual device needs to be
classified taking into account its own specific characteristics with regard to the potential release of free nanoparticles taking also into account
the exposure by the same nanomaterial via daily exposure routes., Also factors such as the number of nanomaterials in or on the product and
the amount of product applied in the intended use have been taken into account. This Table 3 indicates a value for potential contact and/or
external exposure to the nanomaterial and potential internal systemic exposure of all organ systems.
|
IIb (Klasse 2b)
|
— class IIb if they present a low potential for internal exposure
|
- Bone fixation screws/plates with a strongly bound nano-coating
high potential
- Solution administration set made of non-degradable polymer,
with a strongly bound nano-coating
|
Note 1: The high, medium, low or negligible potential of internal exposure is based on the combination of different factors such as the application
site of a medical device, type of contact (e.g. tissue, cells or body fluids), contact time and the type of incorporation of the nanomaterial(s)
(free, fixed, embedded). When the nanomaterial is applied as coating on the surface of the device, it is important to consider the type of
interaction with the material (chemisorption versus physisorption). When the nanomaterial is embedded in a matrix it will be important to
consider the degradability of the material.
Note 2: Internal exposure: exposure may occur via injured skin or mucous membrane, (surgically) invasive devices and implantable devices.
Note 3: Dental materials which are placed in the patient’s teeth in a paste form, where they are cured to a solid form, may release nanomaterials
during a very short exposure time. For most of the exposure time, these devices contain firmly bound nanomaterials. In many cases, grinding
and/or polishing takes place during the application of the device, and could also lead to exposure to nanomaterials. Such nanomaterials do not
necessarily contain the original nanomaterials present in the paste formulation. It is very important to include this aspect in the risk assessment
of such devices. For classification purposes the potential internal exposure to nanomaterials from these devices can generally be considered
negligible. Classification of this kind of materials should be based on the first state, in this example, the short exposure to the paste form which
has higher potential for release than the cured material.
Note 4: Devices with components incorporating nanomaterials that have no intended direct or indirect contact with users or patients, such as
the tires of wheelchairs or walking frames made from rubber reinforced with carbon black nanomaterials, should be exempt from classification
under Rule 19.
Note 5: Medical devices not incorporating or consisting of nanomaterials can still present a potential for internal exposure to nanomaterials due
to degradation or wear processes. While it is very important to include this aspect in the risk assessment of such devices, it is not a factor to
be considered when deciding the classification under Rule 19 since this rule is only applicable for medical devices incorporating or consisting of
Nanomaterials.
|
Rule 19
|
Devices incorporating or consisting of nanomaterial
|
The concept of internal exposure is a key element for the classification incorporating or consisting of nanomaterials. In its ‘Opinion on the
Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’30, the Scientific Committee on Emerging
and Newly Identified Health Risks (SCENIHR) states as a conclusion, that the potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure. Table 3 of the SCENIHR
Opinion estimates both external and internal exposure based on the type of device, type of application, type (location) of contact, and duration
of contact. As indicated in the explanation of table 3 of the SCENIHR opinion, the ‘potential internal systemic exposure of all organ systems’ is
what is listed, which can be expected to occur after release of free nanoparticles from invasive devices as well as from non-invasive devices in
contact with a breached or compromised body surface. This Table 3 uses the terms high/medium/low/negligible, as also used in the classification
rule. This Table 3 could be used as a starting point for correct classification. This Table 3 indicates a value for potential contact and/or external
exposure to the nanomaterial and potential internal systemic exposure of all organ systems However, every individual device needs to be
classified taking into account its own specific characteristics with regard to the potential release of free nanoparticles taking also into account
the exposure by the same nanomaterial via daily exposure routes., Also factors such as the number of nanomaterials in or on the product and
the amount of product applied in the intended use have been taken into account. This Table 3 indicates a value for potential contact and/or
external exposure to the nanomaterial and potential internal systemic exposure of all organ systems.
|
IIa (Klasse 2a)
|
— class IIa if they present a negligible potential for internal exposure
|
- Intravascular catheter for short term use made of non-
degradable polymer, with nanomaterial embedded in the polymer
matrix
- Solution administration set made of non-degradable polymer,
with nanomaterial embedded in the polymer matrix
- Dental filling materials
|
Note 1: The high, medium, low or negligible potential of internal exposure is based on the combination of different factors such as the application
site of a medical device, type of contact (e.g. tissue, cells or body fluids), contact time and the type of incorporation of the nanomaterial(s)
(free, fixed, embedded). When the nanomaterial is applied as coating on the surface of the device, it is important to consider the type of
interaction with the material (chemisorption versus physisorption). When the nanomaterial is embedded in a matrix it will be important to
consider the degradability of the material.
Note 2: Internal exposure: exposure may occur via injured skin or mucous membrane, (surgically) invasive devices and implantable devices.
Note 3: Dental materials which are placed in the patient’s teeth in a paste form, where they are cured to a solid form, may release nanomaterials
during a very short exposure time. For most of the exposure time, these devices contain firmly bound nanomaterials. In many cases, grinding
and/or polishing takes place during the application of the device, and could also lead to exposure to nanomaterials. Such nanomaterials do not
necessarily contain the original nanomaterials present in the paste formulation. It is very important to include this aspect in the risk assessment
of such devices. For classification purposes the potential internal exposure to nanomaterials from these devices can generally be considered
negligible. Classification of this kind of materials should be based on the first state, in this example, the short exposure to the paste form which
has higher potential for release than the cured material.
Note 4: Devices with components incorporating nanomaterials that have no intended direct or indirect contact with users or patients, such as
the tires of wheelchairs or walking frames made from rubber reinforced with carbon black nanomaterials, should be exempt from classification
under Rule 19.
Note 5: Medical devices not incorporating or consisting of nanomaterials can still present a potential for internal exposure to nanomaterials due
to degradation or wear processes. While it is very important to include this aspect in the risk assessment of such devices, it is not a factor to
be considered when deciding the classification under Rule 19 since this rule is only applicable for medical devices incorporating or consisting of
Nanomaterials.
|
null | null | null | null | null | null | null |
Rule 20
|
Invasive devices, intended to administer medicinal product by inhalation
|
This rule covers active and non-active medical devices with a respiratory route of drug delivery.
In contrast to other rules covering devices that administer medicinal products, Rule 20 is also specifically intended to cover medical devices
where the impact of the medical device on the efficacy and safety of the administered medicinal product is critical. The rule also covers drug-
delivery products that are intended to treat life-threatening conditions.
|
IIa (Klasse 2a)
|
All invasive devices with respect to body orifices, other than surgically invasive devices, which
are intended to administer medicinal products by inhalation are classified as class Iia,
|
- Spacer intended for metered dose inhalers
(attached to the inhaler) unless treating life-
threatening conditions.
- Inhalers for nicotine replacement therapy
(nicotine not included)
- Oxygen delivery system with a nasal cannula
unless treating life-threatening conditions
- Inhalers and nebulisers in case their mode of
action has probably no essential impact on the
efficacy and safety of the administered
medicinal product or which are not intended to
treat life-threatening conditions
|
Note 1. ‘Essential impact’ includes drug delivery systems where the device has a significant impact on factors that influence inhaled medicinal
product deposition within the airways including inhalation flow, aerosol velocity, the particle size of the inhaled drug and the amount of drug
reaching the patient.
|
Rule 20
|
Invasive devices, intended to administer medicinal product by inhalation
|
This rule covers active and non-active medical devices with a respiratory route of drug delivery.
In contrast to other rules covering devices that administer medicinal products, Rule 20 is also specifically intended to cover medical devices
where the impact of the medical device on the efficacy and safety of the administered medicinal product is critical. The rule also covers drug-
delivery products that are intended to treat life-threatening conditions.
|
IIb (Klasse 2b)
|
unless their mode of action has an essential impact1 on the efficacy and safety of the
administered medicinal product or they are intended to treat life- threatening conditions, in
which case they are classified as class Iib
|
- Nebulisers (not pre-charged with a specific
medicinal product) where the failure to deliver
the appropriate dosage characteristics could be
hazardous
- Spacer intended for metered dose inhalers
attached to the inhaler
|
Note 1. ‘Essential impact’ includes drug delivery systems where the device has a significant impact on factors that influence inhaled medicinal
product deposition within the airways including inhalation flow, aerosol velocity, the particle size of the inhaled drug and the amount of drug
reaching the patient.
|
null | null | null | null | null | null | null |
Rule 21
|
Devices composed of substances that are introduced via a body orifice or applied to the skin
|
This rule covers a wide range of exclusively substance-based medical devices. In this context, ‘substance’ means any matter that is part of the
medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC. This is provided that they are
not excluded by the MDR (e.g. exclusion criteria in article 1 (6) (h)). The specific medical purpose is specified by the manufacturer from those
listed in the indents of Article 2(1) MDR.
Importantly, if the principal intended action of such substance-based medical devices is achieved or supported by pharmacological,
immunological or metabolic means, Directive 2001/83/EC or Regulation (EC) No 726/2004 or Rule 14 has to be applied to the product,
respectively.
The classification takes into account the site of application of the medical device as well as the site where the medical device performs its action
in or on the human body. For the purpose of this rule nails are also considered as falling under ‘skin’.
Manufacturers of substance-based devices should provide clear information supporting the mode of action through which the substance achieves
the intended specific medical purpose as a basis for the application of this rule, including the site of application as well as the site where the
action is achieved in or on the body.
|
III (Klasse 3)
|
Devices that are composed of substances or of combinations of substances that are intended to be
introduced into the human body via a body orifice or applied to the skin and that are absorbed by or
locally dispersed in the human body are classified as:
— class III if they, or their products of metabolism, are systemically absorbed by the human body in
order to achieve the intended purpose;
| null |
Products acting in the nasal or oral cavity may be to some extent be ingested or inhaled. These products will be class IIa devices if the products
achieve their intended purpose solely in these cavities, and not in the respiratory tract, stomach or lower gastrointestinal tract.
N.B.: examples provided do not imply that the products are a priori qualified as devices. Classification rules apply after the qualification of the
device has been established.
Note 1: There is a normal anatomical connection, the Eustachian tube, from the middle ear to the nasopharynx. If the Eustachian tube was to
be accessed from the nasopharynx direction, this would be considered beyond the pharynx, so this does not fulfil the criteria of ‘as far as the
pharynx’.
Note 2: In the majority of cases the drops would only enter the ear as far as the ear drum. This is regarded as applied to the skin. The outer
layer of the tympanic membrane is epithelium, so if there is an intact tympanic membrane, then the drops are applied only to the skin and has
its action locally, and consequently the device would be class IIa. This will be the case unless the ear drum (tympanic membrane) is perforated
and the product is intended to be used on perforated ear drums.
|
Rule 21
|
Devices composed of substances that are introduced via a body orifice or applied to the skin
|
This rule covers a wide range of exclusively substance-based medical devices. In this context, ‘substance’ means any matter that is part of the
medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC. This is provided that they are
not excluded by the MDR (e.g. exclusion criteria in article 1 (6) (h)). The specific medical purpose is specified by the manufacturer from those
listed in the indents of Article 2(1) MDR.
Importantly, if the principal intended action of such substance-based medical devices is achieved or supported by pharmacological,
immunological or metabolic means, Directive 2001/83/EC or Regulation (EC) No 726/2004 or Rule 14 has to be applied to the product,
respectively.
The classification takes into account the site of application of the medical device as well as the site where the medical device performs its action
in or on the human body. For the purpose of this rule nails are also considered as falling under ‘skin’.
Manufacturers of substance-based devices should provide clear information supporting the mode of action through which the substance achieves
the intended specific medical purpose as a basis for the application of this rule, including the site of application as well as the site where the
action is achieved in or on the body.
|
III (Klasse 3)
|
— class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and
they, or their products of metabolism, are systemically absorbed by the human body;
|
- Na/Mg alginate, xyloglucan
- Fat absorbers that are systemically
absorbed, themselves or their metabolites
|
Products acting in the nasal or oral cavity may be to some extent be ingested or inhaled. These products will be class IIa devices if the products
achieve their intended purpose solely in these cavities, and not in the respiratory tract, stomach or lower gastrointestinal tract.
N.B.: examples provided do not imply that the products are a priori qualified as devices. Classification rules apply after the qualification of the
device has been established.
Note 1: There is a normal anatomical connection, the Eustachian tube, from the middle ear to the nasopharynx. If the Eustachian tube was to
be accessed from the nasopharynx direction, this would be considered beyond the pharynx, so this does not fulfil the criteria of ‘as far as the
pharynx’.
Note 2: In the majority of cases the drops would only enter the ear as far as the ear drum. This is regarded as applied to the skin. The outer
layer of the tympanic membrane is epithelium, so if there is an intact tympanic membrane, then the drops are applied only to the skin and has
its action locally, and consequently the device would be class IIa. This will be the case unless the ear drum (tympanic membrane) is perforated
and the product is intended to be used on perforated ear drums.
|
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