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Regulatory Updates

Key Changes in MDCG 2022-4 Rev 2 for Medical Device Manufacturers

The European Commission has issued the revised MDCG 2022-4 guidance, focusing on appropriate surveillance during the transition from the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to the Medical Device Regulation (MDR).

MedNet EC-REP

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EU Parlament

Let’s dive into the updates:

  1. ‍Alignment with EU 2023/607: MDCG 2022-4 Rev 2 has been adjusted throughout to align with Regulation (EU) 2023/607. This regulation modifies Regulations (EU) 2017/745 and (EU) 2017/746, specifically addressing transitional provisions for certain medical devices and in vitro diagnostic medical devices.
  2. Legacy Device Audit Scope: Notified Body surveillance audits for MDD/AIMDD legacy devices during the MDR transition period are now explicitly outlined. Manufacturers should pay attention to this scope and ensure compliance.

Stay informed and stay compliant!
Read the full guidance here.

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