MDCG 2021-1 关于统一行政做法和替代技术解决办法的指导，直到EUDAMED完全发挥作用.pdf

Medical Devices Medical Device Coordination Group Document MDCG 2021-1 Rev.1 MDCG 2021-1 Rev.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. 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. Page 1 of 31 Medical Devices Medical Device Coordination Group Document MDCG 2021-1 Rev.1 MDCG 2021-1 Rev.1 changes Third Sentence deleted: “Parties should also note that, in principle and unless otherwise concluded by the MDCG, the reporting paragraph obligations with regard to EUDAMED apply to all information generated and collected under the MDR from its date of application (e.g. UDI, certificates) and therefore must be carried out as soon as EUDAMED becomes fully functional” INTRODUCTION Article 33 of Regulation (EU) 2017/745 on medical devices 1 (MDR) requires the Commission to set up a European database on medical devices (‘EUDAMED’). According to Article 33(2) of the MDR, Eudamed will be composed of six different electronic systems