Medical Device Regulatory Guide

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Update to Implementation & Preparedness Plan for IVDR 🔥

The EC has released an updated “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”. It serves as a “living document to monitor” the priorities of the MDCG-endorsed principles for IVDR.

 The plan considers:

(i)                  Contingency Planning and Monitoring

(ii)                Availability of Notified Bodies

(iii)               EU Reference Labs

(iv)               Performance evaluations and expert panels, among other topics.

 đź”— Original Document :  https://ec.europa.eu/health/system/files/2022-02/md_joint-impl-plan_en.pdf