MDCG 2020-10/2 Rev.1
Appendix: Clinical investigation summary safety report form
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This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
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This is the original MDCG Template that is part of the MDCG 2020-10/1 document Rev. 1.
Revision History
October 2022
Rev.1
Readline version
May 2020
Rev.0