Our glossary for guidance - Category AIMDD

COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

'Active implantable medical device' means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice , and which is intended to remain after the procedure.

[Definition according to (90/385/EEC) Article 1 No. 2c]

'Active medical device' means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

[Definition according to (90/385/EEC) Article 1 No. 2b]

'Custom-made device' means any active implantable medical device specifically made in accordance with a medical specialist's written prescription which gives, under his responsibility, specific design characteristics and is intended to be used only for an individual named patient.

[Definition according to (90/385/EEC) Article 1 No. 2d]

'Device intended for clinical investigation' means any active implantable medical device intended for use by a specialist doctor when conducting investigations in an adequate human clinical environment.

[Definition according to (90/385/EEC) Article 1 No. 2e]

'Intended purpose' means the use for which the medical device is intended and for which it is suited according to the data supplied by the manufacturer in the instructions.

[Definition according to (90/385/EEC) Article 1 No. 2f]

'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception, and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means.

[Definition according to (90/385/EEC) Article 1 No. 2a]

'Putting into service' means making available to the medical profession for implantation.

[Definition according to (90/385/EEC) Article 1 No. 2g]