The Medical Device Coordination Group (MDCG) of the EU established the Clinical investigation application/notification document MDCG 2021-08 in May 2021. This document is developed as a template to support sponsors of a clinical investigation in the process of application procedure for the clinical investigation.
In the document, you can find an application/notification form under the MDR for clinical investigation procedure. There are also templates of clinical investigation supporting documents such as Checklist of general safety and performance requirements, standards, common specifications, and scientific advice.
These documents were established to support document traceability during the absence of EUDAMED. However, once the EUDAMED module for clinical investigations is fully functional, the validity of these templates are going to be terminated.
Please, note that the document is not binding and doesn’t reflect the official position of the European Commission. Before using these templates, the MDCG suggests checking the individual Member State where the clinical investigation is planned to be conducted for any specific national requirements for implementation.
The full text of MDCG 2021-08 itself you can find here.
The information has been prepared by the GMA Consult Group team.
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