2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.

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Presentation transcript:

2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical documentation

2.2. Corrective actions Possibility of consulting The corrective action depends on the level of non-compliance: first, to make the product comply with the provisions ultimately, all appropriate measures shall be taken

2.3. Complementary activities Market surveillance authorities should: act in collaboration with manufactures and suppliers, take appropriate action against the person who has affixed the CE marking who are responsible for the non-compliance of the product warn consumers who might be at risk destroy dangerous products prohibit certain products require the withdrawal of certificates

3. Safeguard clause procedure The competent authorities have to restrict or forbid or withdraw the dangerous products from the market Safeguard clause procedure is restricted to products which are: covered by New Approach directives CE marked presented a substantial hazard The safeguard clause procedure can restrict, forbid or withdraw the dangerous product from the market Member States must notify the Commission immediately after taking action National action to be justified, Commission informs the other Member States

4. Protection of CE marking Authorities must check that the affixing and use of the CE marking is correct Authority has to take appropriate corrective action Member State must notify to the Commission and to the other Member States

5. Information exchange system A rapid exchange information system has been set up by the directive on General Product Safety (RAPEX) Information system for medical devices Community injury data collection and information exchange system

6. Administrative co-operation Administrative co-operation is an obligatory task Member States need to communicate to the Commission and the other Member States National market surveillance authorities should give information Professional secrecy Committees established under the directives

7. Products imported from third countries Manufacturer established in a third country is responsible in the same way Customs authorities should suspend the release of goods: dangerous products (serious and immediate risk to health and safety) no documents accordance with applicable rules Relationship between Customs and Market Surveillance Authorities