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EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation

The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...

EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...

European Commission (EC) updated guide on Good Lay Summary Practice

The European Commission (EC) on 04-October-2021 has put out recommendations on finest practices for preparation, translation and...

MDCG Guidance on UDI Integration -European Comission

Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...