医疗器械分类规则 – ALL

CLASSIFICATION RULES

4. NON-INVASIVE DEVICES
4.1. Rule 1

All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

Rule 1 Examples

Class I: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.

[Class I Device examples]

– 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 gels

– 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.

4.2. Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:

— if they may be connected to a class IIa, class IIb or class III active device; or

— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.

In all other cases, such devices are classified as class I.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 2 devices Examples]

Class IIa: 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, device examples:

– 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)

Class IIb: 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

Class I: 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 medicines 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.

4.3. Rule 3

All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.

All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 3 devices Examples]

Class IIb: 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

Class IIa: 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.

Class III: 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.

4.4. Rule 4

All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:

— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;

— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;

— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and

— class IIa in all other cases.

This rule applies also to the invasive devices that come into contact with injured mucous membrane.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 4 devices Examples]

Class I:  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

Class IIb:

– 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

Class IIa:

– 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

Class IIa:

– class IIa in all other cases

Class I:  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.

Explanation of special concepts:

Breached dermis or mucosa: the wound exposes at least partly the subcutaneous tissue.

Secondary intent: the wound heals by first being filled with granulation tissue; subsequently the epithelium grows back over the granulation tissue and the wound contracts. In contrast, primary intent implies that the edges of the wound are close enough or pulled together, e.g. by suturing, to allow the wound to heal before formation of granulation tissue.

5. INVASIVE DEVICES
5.1. Rule 5

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;

— class IIa if they are intended for short-term use, 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

— class IIb if they are intended for long-term use, 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.

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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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).

[Rule 5 devices Examples]

Class I:  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

Class IIa:

– 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

Class I:

– 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

Class IIb:

– 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

Class IIa:

– 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

Class IIa: 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.

5.2. Rule 6

All surgically invasive devices intended for transient use are classified as class IIa unless they:

— 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;

— are reusable surgical instruments, in which case they are classified as class I;

— 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;

— are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or

— 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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 6 devices Examples]

Class IIa: 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

Class III:

– 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 III3;  – 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

Class I:

– 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

Class III:

– 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

Class IIb:

– 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

Class IIb:

– have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; Viscoelastic solution for ophthalmic surgery

Class IIb:

– 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

Practical issues of classification/Explanation of special concepts

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 use.

5.3. Rule 7

All surgically invasive devices intended for short-term use are classified as class IIa unless they:

— 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;

— 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;

— are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;

— 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

— are intended to administer medicines, in which case they are classified as class IIb.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 7 devices Examples]

Class IIa: 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

Class III: 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

Class III: 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

Class IIb: are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;   Brachytherapy devices

Class III: have a biological effect or are wholly or mainly absorbed in which case they are classified as class III; Absorbable sutures.

Class IIb: 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

Class IIb: are intended to administer medicines, in which case they are classified as class IIb.   Temporal dialysis catheter, CVVH catheter.

Note 1: Administration of medicinal products is more than just channeling, 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.

5.4. Rule 8

All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:

— are intended to be placed in the teeth, in which case they are classified as class IIa;

— 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;

— have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;

— are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;

— are intended to administer medicinal products, in which case they are classified as class III;

— are active implantable devices or their accessories, in which cases they are classified as class III;

— are breast implants or surgical meshes, in which cases they are classified as class III;

— 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

— 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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 8 devices Examples]

Class IIb: 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 surgery

– Pedicle screws

Class IIa:

– 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

Class III:

– 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

Class III:

– 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)

Class III:

– 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

Class III:

– are intended to administer medicinal products, in which case they are classified as class III;

– Rechargeable non-active drug delivery systems

– Peritoneal dialysis

Class III:

– 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 not:

– 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

Class III:

– 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

Class III:

– 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

Class III:

– 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.

6. ACTIVE DEVICES
6.1. Rule 9

All active therapeutic devices intended to administer or exchange energy are classified as class IIa 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.

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.

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.

All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 9 – Active therapeutic devices intended to administer or exchange energy1, 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

[Rule 9 devices Examples]

Class IIa: 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

Class IIb: 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)

Class IIb: 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

Class IIb: 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

Class III: 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).

6.2. Rule 10

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, except for devices intended to illuminate the patient’s body, in the visible spectrum, in which case they are classified as class I;

— if they are intended to image in vivo distribution of radiopharmaceuticals; or

— if they are intended to allow direct diagnosis or monitoring of vital physiological processes, 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.

Active devices intended to emit ionizing radiation 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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 10 devices Examples]

Class IIa: 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

Class I:  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

Class IIa:

– if they are intended to image in vivo distribution of radiopharmaceuticals; or

– Gamma cameras

– Positron emission tomography and single photon emission computer tomography

Class IIa:

– if they are intended to allow direct diagnosis or monitoring of vital physiological processes,

– Electrocardiographs

– Electroencephalographs

– Electronic thermometers

– Electronic stethoscopes

– Electronic blood pressure measuring equipment

Class IIb: 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, and oxygen saturation.

Class IIb: Active devices intended to emit ionizing radiation4 and intended for diagnostic or therapeutic radiology5, including interventional radiology devices5 and devices which control or monitor6 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.

6.3. Rule 11

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:

— death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or

— a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, 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.

All other software is classified as class I.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

Rule 11   Examples

Class IIa: 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.

Class III:

— 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.

Class IIb:

— 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.).

Class IIa: 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.

Class IIb: 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.

Class I:  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

6.4. Rule 12

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, 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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 12 devices Examples]

Class IIa: 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

Class IIb: 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

6.5. Rule 13

All other active devices are classified as class I.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 13 – All other active devices

This is a fallback rule to cover all active devices not covered by other rules.

[Rule 13 devices Examples]

Class I:  All other active devices are classified as class I.

– Electric wheelchairs

– Dental curing lights

– Electric hospital beds

– Patient hoists

– Dental patient chairs

7. SPECIAL RULES

7.1. Rule 14

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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 14 devices examples]

Class III: 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 substances 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.

7.2. Rule 15

All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 15 devices Examples]

Class IIb: 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)

Class III: 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)

7.3. Rule 16

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.

All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.

This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 16 devices Examples]

Class IIb: 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

Class IIa: 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

Class IIb: unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, 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

Class I: 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.

7.4. Rule 17

Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 17 devices Examples]

Class IIa: 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.

7.5. Rule 18

All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, 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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 18 devices Examples]

Class III: All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, 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

Class I:  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.

7.6. Rule 19

All devices incorporating or consisting of nanomaterial are classified as:

— class III if they present a high or medium potential for internal exposure;

— class IIb if they present a low potential for internal exposure; and

— class IIa if they present a negligible potential for internal exposure.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

Rule19 Examples

All devices incorporating or consisting of nanomaterial are classified as Class III:

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

Class IIb:

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

Class IIa:

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.

7.7. Rule 20

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, unless their mode of action has an essential impact 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.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 20 devices Examples]

Class IIa: 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

Class IIb: 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.

7.8. Rule 21

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;

— 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;

— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and

— class IIb in all other cases.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

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.

[Rule 21 devices Examples]

Class III: 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;

Class II:

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

Class IIa:

class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx1, and achieve their intended purpose on those cavities; and

– Substance-based formulations for skin treatment

– Salt water used e.g. as nose or throat sprays

– Oral cough treatments achieving their intended purpose in the oral cavity as far as the pharynx

Class IIb:

class IIb in all other cases.

– Simethicone preparations for oral administration

– Active coal for oral administration

– Gel for vaginal moisturizing / vaginal lubricants

– Eye drops for hydration

– Ear drops

– Medical devices, for oral administration, for the treatment of diarrhoea, e.g. kaolin, diosmectite

– Medical devices, for oral administration, for the treatment of obesity, e.g. fructooligosaccharides, glucomannan

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.

7.9. Rule 22

Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed-loop systems or automated external defibrillators, are classified as class III.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 22 Active therapeutic devices, with an incorporated diagnostic function

This rule is intended for therapeutic devices whose intended functionality is dependent to a significant degree on an integrated or incorporated diagnostic function.

Automated or ‘closed-loop’ therapeutic systems are systems in which relevant biological conditions are automatically monitored (uses feedback from physiological sensors) and is used to adjust a therapy in order to maintain or achieve a particular physiological state. Such devices are normally used in precision medicine and/or personalised therapies for obtaining optimal therapeutic efficacy. This rule covers systems such as autonomic pharmacological (drug-delivery) and neuromodulation systems.

[Rule 22 devices Examples]

Class III: Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.

– Automated external defibrillators (AED) including their pads/electrodes

– Semiautomatic external defibrillators

– Automated closed loop insulin delivery system

– Automated external infusion pumps with integrated sensors to adapt the infusion therapy

– Devices in brain-computer interfaces (BCIs) – used for e.g. motor control in severely paralyzed patients

– Closed-loop systems for deep brain stimulation (DBS) treatment of various neurological conditions

– Closed-loop dynamic neurochemical control of therapeutic interventions e.g. target-controlled anaesthesia / infusion systems

Note 1. ‘Integrated or incorporated diagnostic function’ means the functionality of a system including a physiological sensors e.g. the AED electrodes/pads using a feedback control to process and record changes in the patient’s physiological state to continuously adjust a therapy. The diagnostic function can be physically integrated or a component of an external sub-system.

[ANNEX XVI. LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)]

1. Contact lenses or other items intended to be introduced into or onto the eye.

2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.

3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.

4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.

6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.