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
Author
Let’s dive into the updates:
- 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.
- 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.
Related Articles
CE marking UK: Indefinite recognition planned, UK Responsible Person still required
Great Britain plans to drop the 2030 end date for CE marked MDR and IVDR devices. The UK Responsible Person remains mandatory.
IVDR Rule 7: When Is IVD Control Material Class B? (MDCG 2020-16 Rev. 5)
MDCG 2020-16 Rev. 5 clarifies when IVD control material without an assigned value falls under class B, and when another rule applies.
MHRA Consultation 2026: The Fee Increases Coming for Medical Device Manufacturers in 2027
The MHRA has opened a consultation on fee increases from April 2027 — including a proposed 70 % rise in the post-market surveillance fee. Manufacturers have until 25 September to respond.
Stay Updated
Get the latest regulatory updates and industry insights delivered to your inbox.
Subscribe to Updates