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Regulation of putting medical devices into circulation in the European Union

Any product is approved to put into circulation in member states of the EU, so now already also in Hungary, if it is labeled with the CE conformance marking. Proceedings of evaluation of conformance are determined in the EU by directives. Each directive becomes obligatory through adopting them by a national rule. In Hungary, this acceptation is 100 per cent.

CE marking is not a quality indication but shows that the product is conform to all essential (i.e. safety-related) requirements of the applicable directives at the date of manufacturing. If the product is conform to standards, harmonized to a directive, it must be assumed that it satisfies also the essential requirements from that point of view to which the given standard relates.

If a product conforms to the essential requirements then it is entitled to bear the CE marking. So the free flow of products between member states is realized. Products, labeled with CE marking, do not need to be tested again, and testing again is generally prohibited. Exception is if there is a suspicion that it bears CE-marking illegally, or if it caused or could be caused an accident. Suspicion may arise from the side of user or a concurrent firm (not from state institutions). In this case the competent authority must be informed. This authority is generally the market surveillance, in case of medical devices the Directorate. Otherwise, competent authority performs supervision also randomly. This is state sphere of authority in all countries; therefore it has everywhere an unfortunately low capacity.

Most of directives rank products into classes (which are ultimately safety classes but this word is not mentioned). Ranking rules are different, depending on directives. There may be a need for contribution of a so-called notified body (NB), depending on the ranking. If a product has a low risk only and do not require contribution of a NB, manufacturer has to verify its conformity to the essential requirements, and can put the CE marking on it on its own authority. If contribution of a NB is needed, the NB has to certify the conformity to the essential requirements according to the requirements of the directive.

Full text of directives can be downloaded and printed from the website of EU12 free, as well as data of competent authorities and notified bodies, moreover, list of harmonized standards. The standards themselves, however, can be purchased only.


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