Medical Device Regulatory Guide

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Joint Implementation & Preparedness Plan for IVDR ✅

Agreed between the #EC and #MDCG, this plan outlines a number of actions, including:

(1)  Contingency planning & monitoring

(2)  Availability of notified bodies

(3)  EU reference laboratories

(4)  Common specifications

(5)  Guidance for notified bodies

(6)  Performance evaluation and expert panels

(7)  Standards

(8)  Companion diagnostics

(9)  In-house devices

 

🔗 https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_joint-impl-plan_en.pdf