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MDCG offers Guidance on Clinical Investigations – Europe

Updated: Aug 21, 2021

The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be used to fulfill the application/notification submission requirements for clinical investigations under the Medical Device Regulation (MDR) prior to the availability of the Eudamed clinical investigations and performance studies module.

Also, MDCG endorsed documents and other guidance in May 2021. On 23 April 2020 the Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions.

The templates include the clinical investigation application/notification form; addendums for the additional investigational device(s), additional comparator device(s) and additional investigation site(s); clinical investigation supporting documents; and a checklist of general safety and performance requirements, standards, common specifications, and scientific advice.

Also there was guidance recently in April-21 on the Questions & Answers regarding the clinical investigation.


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