Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in Vitro Diagnostic Medical Devices
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Total Pages | : |
Release | : 2018 |
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ISBN | : 9789279904097 |
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The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.