THE NEW APPROACH IN HARMONIZATION

In vitro diagnostic medical devices

1) OBJECTIVE

2) COMMUNITY MEASURE

3) CONTENTS

2. These devices are products used for the in vitro analysis of tissues or substances (blood, specimens) from the human body. The types of analysis covered are as follows:

• state of health;
• congenital diseases or anomalies;
• checking the progress of courses of treatment;
• determining compatibility in the case of organ or blood donations.

4. Harmonized European standards on the prevention of risks relating to the design, manufacture and packaging of products are drawn up by the European standards bodies on the basis of the essential requirements. These standards, which are not mandatory, are published in the Official Journal of the European Communities in the form of national standards with identical contents.

5. Any product manufactured in accordance with harmonized standards is presumed to conform to the essential requirements.

6. The product conformity assessment procedures and the essential requirements are based on the modular approach set out in Council Decision 93/465/EEC. Conformity assessment is the responsibility of:

• manufacturers or their authorized representatives themselves; or
• more rarely, bodies which may be designated by the Member States in accordance with joint evaluation criteria and notified to the Commission and the other Member States.

CEmarking

• confirms that they conform to the provisions of this proposal;
• consists of a single graduated drawing the "CE" mark, accompanied by the identification number of the notified body responsible for following the procedures;
• is affixed by the manufacturer or his authorized representative established in the Community.

CE

marking

9. Any other mark may also be affixed to the devices provided there is no risk of it being confused with the conformity mark.

10. Penalties must be imposed by the Member States if they find that the mark has been unduly affixed.

11. There is a safety clause which allows any Member State, in an emergency, to withdraw the devices, when correctly installed, maintained and used for their intended purpose, from the market if they may compromise the safety of property and the health and/or safety of users or third parties.

12. Administrative cooperation and the exchange of information between the Member States are necessary to guarantee conformity with this proposal.

13. Any fault (malfunction, inadequate labelling, etc.) which is connected with the use of a device bearing the CEmarking and which has caused serious risks to the health of a user or led to the recall of devices of the same type must be recorded and evaluated centrally.

14. A European databank, accessible to the competent authorities of the Member States, will contain all the regulatory data relating to implementation of the Directive (registration of manufacturers and devices, certificates issued, etc.).

15. There will be transitional periods of five and seven years during which the Member States may authorise the placing on the market and the putting into service respectively of devices conforming to the rules in force in their territory on the date of adoption of the Directive.

4) DEADLINE FOR IMPLEMENTATION OF THE LEGISLATION IN THE MEMBER STATES

5) DATE OF ENTRY INTO FORCE (if different from the above)

6) REFERENCES