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