JD Supra

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively. New guidance ...
Yahoo Finance

EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Training Webinar: Explore Impact on Regulatory Strategies, and Practical Steps for Achieving Compliance

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...
JD Supra

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition ...
RAPS

MDCG posts guidance on UDI integration within a QMS

The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s ...
Regulatory Affairs Professionals Society

MDCG updates guidance on device classification, EMDN, and supply disruptions

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...