UK MHRA Updates: Draft Policy for International Recognition Framework & New IVD Consultation
21 May 2024
Progress Update: Commission Proposal to Extend the IVDR Transition Period & Rollout EUDAMED
28 May 2024Table of Contents
MDCG 2022-4 on MDR Appropriate Surveillance has been updated. It is available: HERE
Overview
The updates are to:
- Align with the timing and conditions of the MDR transition extension, under Regulation 2023/607
- Establish that EUDAMED modules may become mandatory before the entire system is fully functional
The general scope and intent of the guidance document remains the same:
To outline the requirements for Notified Body surveillance audits for MDD/AIMDD legacy devices during the MDR transition period.
For more information on:
- The scope of MDCG 2022-4, please read our February 2022 update
- MDCG 2022-4 rev.1, please read our December 2022 update
Examples of Changes
There are a number of good quality text comparison tools online, if you would like to perform a side-by-side evaluation.
Below we highlight some of the changes between Rev.1 and Rev.2.
