医疗器械分类规则 – Invasive devices

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:

– Artificial ligaments for reinforcement.

– 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.