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Commission issues new guidance documents for MDR/IVDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission issued new guidance documents in December 2022 relating to both the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746), as follows:

  • MDCG 2022-19: Performance study application/notification documents under Regulation (EU) 2017/746
  • MDCG 2022-20: Substantial modification of performance study under Regulation (EU) 2017/746
  • MDCG 2022-4 rev.1: Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions – devices covered by MDD or AIMDD certificates
  • MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

In addition, Version 2 of the Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 was published.