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, improving clinical safety and creating fair market access for manufacturers and healthcare professionals.
Unlike directives, regulations do not need to be transposed into national law. The MDR and the IVDR will therefore limit interpretation discrepancies across the EU market.
The MDR has been fully applicable since 26 May 2021 and the IVDR since 26 May 2022, following the transition periods.
If you manufacture, distribute or procure medical devices, or have other responsibilities under the new Regulations, please take advantage of the delay by making absolutely sure that you will be ready for the new deadline.