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Getting ready for the new regulations

Getting ready for the new regulations

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 will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers.

Unlike Directives, Regulations do not need to be transposed into national law. The MDR and the IVDR will therefore limit discrepancies in interpretation across the EU market.

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