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.
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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.