The EU Medical Device Regulation (MDR) has come into effect from 26th May 2021, after the 3-year transition timeline and an additional one-year extension due to the COVID-19 pandemic. The devices which are being launched in the EU market now must comply with these regulations and shall be CE certified as per EU MDR by the Notified Bodies accredited under these regulations. The devices which have already been CE certified as per EU MDD however, have grace periods before they have to fully comply with the EU MDR requirements. During this grace period, the devices certified under both EU MDD and EU MDR will co-exist in the market with equal status and without being subjected to discrimination.
The MDR - Transition Timeline and New Device Classifications
The European Medical Device Regulation (MDR) will be fully effective in all the EU member states and the European Free Trade Association (EFTA) States from May 2021 and provides manufacturers a transition period of 4 years for complete EU MDR Certification.
The new European Medical Device Regulation (MDR), as observed, have also brought changes to existing device classification system such as:
From identifying exact changes to be made to implementing them in real-time, manufacturers may have to navigate through array of challenges to comply with EU MDR requirements. Right from decoding the new structure, classifying a device accurately, to collate and submit all the data, a more detailed and cross-functional Regulatory approach will be required for manufacturers, to cope with the new European Medical Device Regulations. With a stringent gap analysis, Freyr assists clients with the status-quo and there by provides necessary Regulatory action needed for the transition and EU MDR Compliance.