MD5/IVD5: Responsible and experienced PRRCs for MDR and IVDR

By Rachel Drapela2024-11-08T06:57:00

Key points:

The session focused on the role and responsibilities of the the person responsible for regulatory compliance (PRRC) under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR), its potential misinterpretations and challenges
Notified bodies (NBs) have identified several gaps in understanding and evidencing for manufacturers who implement the PRRC role

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