Transcription of MDCG 2021-1 Rev.1 Guidance on harmonised administrative ...
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MDCG 2021-1 Rev.1 Guidance on harmonised administrative ...
Medical Devices Medical Device Coordination Group Document MDCG 2021-1 Page 1 of 31 MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional May 2021 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.
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017, p. 1–175.
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