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.pdfVIP

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