EU MDR Compliance, EU MDR regulations, European Medical Device Regulation

The New Medical Device Regulation (MDR), which which is replaced by European MD Directive 93/42/EEC (EU MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMD) had a timeline of May 2020. The timelines have been extended to May 2021, due to the COVID-19 pandemic. These extended timelines have given an opportunity for the manufacturers with the devices already being marketed, as well as those planning to introduce in coming years to comply with EU MDR regulations and obtain CE marking.

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