What is the EU Medical Device Regulation (MDR)?

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

EU MDR (Regulation 2017/745) is the EU regulatory framework for medical devices placed on the EU market. It replaced the MDD (Medical Device Directive) with stricter requirements: (1) All devices need a Unique Device Identifier (UDI), (2) Higher risk Class II-III devices require Notified Body assessment, (3) EUDAMED (European Medical Device database) registration required, (4) Post-market surveillance and clinical evidence requirements are stricter. Indian medical device manufacturers must comply with EU MDR before EU market entry.

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