EUROPA

SUMMARY

This directive applies to medical devices * and their accessories *.

Scope

It does not apply to:

• devices used for in vitro diagnosis;
• active implantable devices;
• medicinal products for human use, including medicinal products derived from blood;
• cosmetic products;
• partly to human blood,blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
• transplants, tissues and cells of human origin or to products incorporating or derived from tissues or cells of human origin with the exception of devices referred to in paragraph 4a;
• transplants, tissues and cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

Essential requirements

Medical devices must not compromise the clinical condition or the safety of patients. In addition, they must not present any risk to the persons implanting them, or to other persons.

These devices must achieve the performances intended by the manufacturer. They must be designed in such a way as to withstand the storage and transport conditions.

Harmonised standards

Member States shall publish the national standards implementing the corresponding harmonised standards, which shall also include the monographs of the European Pharmacopoeia.

Member States shall assume that devices meet the essential safety requirements set out in this Directive where the devices comply with the national standards transposing the relevant applicable harmonised standards.

Conformity procedures

All devices must be subjected to a conformity assessment procedure. Member States shall designate independent bodies contributing to the application of these procedures for devices other than those which represent a minimal risk.

Placing on the market and free movement

Member States shall take necessary steps to ensure that devices may be placed on the market and put into service only if they meet the requirements of this Directive and do not compromise the safety and health of patients, users and other persons when properly implanted, maintained and used in accordance with their intended purposes.

Member States not must not impede the placing on the market, free movement and putting into service of devices meeting the essential safety criteria set out in the annexes to the Directive and bearing the CE mark.

European databank

The aim of the European databank is to store the data required by law. The latter shall be made available to the competent authorities and shall contain:

• data on registration of manufacturers;
• data relating to certificates issued, amended, suspended, withdrawn or refused;
• data obtained in accordance with the vigilance procedure;
• data on clinical investigations.

Vigilance

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. This information must be recorded and evaluated by Member States.

Surveillance

Notified bodies shall be authorised to carry out inspections of manufacturers. For their part, manufacturers must provide the inspectors with all relevant information.

Safeguard measures

Member States must take all appropriate measures to withdraw from the market devices conforming to the Directive which are liable to compromise the health and/or safety of patients, users or third parties. The provisional measures taken must be notified to the Commission.