MDCG 2020-14 在MDR法规进行监督审核时，为公告机构使用MDSAP审核报告提供的指引.pdf

Medical Devices Medical Device Coordination Group Document MDCG 2020-14 MDCG 2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) August 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 a representative of the European Commission chairs it. 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. 1 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) Background In fulfilling the EU’s commitment to encourage notified bodies to make use of audit reports from the Medical Device Single Audit Program (MDSAP) in a manner that is compatible with EU legislative requirements, the Medical Device Coordination Group (MDCG) endorsed this guidance which has been developed by a group of experts comprised of interested Member State representatives, notified body associations and stakeholders. Scope The purpose of this document is to provide guidance to notified bodies on how to take into account MDSAP Medical Device Regulatory Audit Reports1