Medical devices

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

By 2024-11-08T06:57:00

MD5 - NatashaBankowski

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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