What are the medical device risk classes in place in Europe?
Examples of product Classifications can be found under the following Weblink:
The regulatory requirements and classification criteria are described as follows:
COUNCIL DIRECTIVE 93/42/EEC
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).
1. Definitions for the classification rules
Normally intended for continuous use for less than 60 minutes.
Normally intended for continuous use for not more than 30 days.
Normally intended for continuous use for more than 30 days.
1.2. Invasive devices
A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
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.
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.