Medical Device Risk Classification

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Classification
What are the medical device risk classes in place in Europe?

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MEDDEV 2. 4/1 Rev. 9 Classification of medical devices

The regulatory requirements and classification criteria are described as follows:

COUNCIL DIRECTIVE 93/42/EEC
Article 9
Classification

1.  Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.

2.  In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject.

3.  Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

ANNEX IX
CLASSIFICATION CRITERIA

I.   DEFINITIONS
1.   Definitions for the classification rules

1.1.   Duration
Transient
Normally intended for continuous use for less than 60 minutes.

Short term
Normally intended for continuous use for not more than 30 days.

Long term
Normally intended for continuous use for more than 30 days.

1.2.   Invasive devices
Invasive device
A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Body orifice
Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

Surgically invasive device
An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.

For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices.

Implantable device
Any device which is intended:

  • to be totally introduced into the human body or,
  • to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.

1.3.   Reusable surgical instrument
Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out.

1.4.   Active medical device
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device. 

1.5.   Active therapeutical device
Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.

1.6.   Active device for diagnosis
Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

1.7.   Central circulatory system
For the purposes of this Directive, ‘central circulatory system’ means the following vessels:

  • arteriae pulmonales,
  • aorta ascendens,
  • arcus aorta,
  • aorta descendens to the bifurcatio aortae,
  • arteriae coronariae,
  • arteria carotis communis,
  • arteria carotis externa,
  • arteria carotis interna,
  • arteriae cerebrales,
  • truncus brachiocephalicus,
  • venae cordis,
  • venae pulmonales,
  • vena cava superior,
  • vena cava inferior.

1.8.   Central nervous system

For the purposes of this Directive, ‘central nervous system’ means brain, meninges and spinal cord.

II.   IMPLEMENTING RULES
2.   Implementing rules

2.1.  Application of the classification rules shall be governed by the intended purpose of the devices.

2.2.  If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.

2.3.  Software, which drives a device or influences the use of a device, falls automatically in the same class.

2.4.  If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use.

2.5.  If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the higher classification shall apply.

2.6. In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means ‘an uninterrupted actual use of the device for the intended purpose’. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.

III.   CLASSIFICATION

1.   Non-invasive devices

1.1.   Rule 1
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.

1.2.   Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa:

  • if they may be connected to an active medical device in Class IIa or a higher class,
  • if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues,

in all other cases they are in Class I.

1.3.   Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa.

1.4.   Rule 4
All non-invasive devices which come into contact with injured skin:

  • are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,
  • are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,
  • are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound.

2.   Invasive devices

2.1.   Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:

  • are in Class I if they are intended for transient use,
  • are in 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 a nasal cavity, in which case they are in Class I,
  • are in 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 a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.

2.2.   Rule 6
All surgically invasive devices intended for transient use are in 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 these parts of the body, in which case they are in Class III,
  • reusable surgical instruments, in which case they are in Class I,
  • intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
  • intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
  • intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
  • intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.

2.3.   Rule 7
All surgically invasive devices intended for short-term use are in Class IIa unless they are intended:

  • either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
  • or specifically for use in direct contact with the central nervous system, in which case they are in Class III,
  • or to supply energy in the form of ionizing radiation in which case they are in Class IIb,
  • or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III,
  • or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class IIb.

2.4.   Rule 8
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:

  • to be placed in the teeth, in which case they are in Class IIa,
  • to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,
  • to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,
  • or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III.

3.   Additional rules applicable to active devices

3.1.   Rule 9
All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from 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 in Class IIb.

All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.

3.2.   Rule 10
Active devices intended for diagnosis are in Class IIa:

  • if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient’s body, in the visible spectrum,
  • if they are intended to image in vivo distribution of radiopharmaceuticals,
  • 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, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb.

Rule 11
All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in 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 in Class IIb.

3.3.   Rule 12
All other active devices are in Class I.

4.   Special Rules

4.1.   Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.

All devices incorporating, as an integral part, a human blood derivative are in Class III.

4.2.   Rule 14
All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III.

4.3.   Rule 15
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specifically to be used for disinfecting medical devices are in Class IIa. Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.

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

4.4.   Rule 16
Devices specifically intended for recording of X-ray diagnostic images are in Class IIa.

4.5.   Rule 17 All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only.

5.   Rule 18 By derogation from other rules, blood bags are in Class IIb.