Rådsdirektiv 90/385/EØF av 20. juni 1990 om tilnærming av medlemsstatenes lovgivning om aktive implanterbare medisinske innretninger
BAKGRUNN (fra Kommisjonens faktaark om direktivet, engelsk utgave)
Active implantable medical equipment
This Directive aims to harmonise and improve the level of safety to be met by active implantable medical devices used in human medicine. It is based on the principles of the "New Approach to Technical Harmonisation and Standards". In line with this new approach, the design and manufacture of medical devices is subject to essential requirements concerning protection of the health and safety of patients and users of these devices.
This Directive shall apply to active implantable medical devices.
Placing on the market and free movement
Member States must not impede the placing on the market, free movement and implantation of devices meeting the essential safety criteria set out in the annexes to the Directive and bearing the CE mark. The marketing and implantation of devices not bearing the CE mark will, however, be authorised for devices intended for clinical assessment or for prototypes designed for research purposes.
Member States shall publish the national standards implementing the corresponding harmonised standards. They should assume that devices complying with these harmonised standards meet the essential safety requirements set out in the Directives. Where devices and national standards are found not to meet the essential safety and health requirements, special measures are laid down: consultations with a standing committee and measures to withdraw a product from the market or revoke a standard.
The manufacturer must immediately inform the competent authorities of any incident causing death or damage to the health of a patient, by applying the procedures of a technico-vigilance system.
All devices must be subjected to a conformity assessment procedure. Member States shall designate bodies responsible for applying these procedures.
The annexes to the Directive provide information on the following aspects:
* the essential safety requirements imposed on devices;
* CE type examination;
* EC verification;
* EC declaration of conformity to type;
* statement concerning devices intended for special purposes;
* clinical evaluation;
* minimum criteria to be met when designating inspection bodies to be notified;
* a sample of the CE mark of conformity.
Proposal of December 2005
In December 2005, the Commission proposed amendments to this Directive, to Directive 93/42/EEC relating to active implantable medical devices, and to Directive 98/8/EC concerning the placing of biocidal products on the market.
This Directive should be amended in order to clarify the current provisions and add new ones on, for example, data and clinical assessment or custom-made devices. Directive 90/385/EC should be brought into line with the other Directives on medical devices. Directive 98/8/EC should be amended to exclude in vitro diagnostic medical devices from its scope.
Key terms used in the act
* active implantable medical device: 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.
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