mdcg_2020-6 关于传统设备的充分临床证据的指导.pdfVIP

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mdcg_2020-6 关于传统设备的充分临床证据的指导.pdf

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Medical Device Medical Device Coordination Group Document MDCG 2020-6 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and notified bodies April 2020 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. Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and notified bodies Page 2 of 22 Table of contents 1. Definitions 4 1.1. Terms defined in MDR Article 2 4 1.2. Additional terms not defined in MDR Article 2 4 2. Reference documents 6 3.