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Rules - IVDD The Purpose of the New Rules for In Vitro Diagnostic Medical DevicesThe purpose of the Directives is to remove the trade barriers represented by the different national certification systems up to now.Today the manufacturers may therefore, without restrictions, market in vitro diagnostic medical devices in the EU and EFTA countries that comply with the new requirements without having the devices approved according to the various national rules first. At the same time it has been the objective of the EU countries to ensure that the Single Market for in vitro diagnostic medical devices did not result in the impairment of the safety level anywhere in Europe. On the contrary, the Directives aim at maintaining and improving safety. Back to index |
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