Medical Device Medical Device Coordination Group Document MDCG 2020-5 MDCG 2020-5 Clinical Evaluation - Equivalence 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)...
MDCG 2020-1 MDCG Position Paper on 关于在成员国使用 EUDAMED August 2020 5 the use of the EUDAME actor注册模块和单一注册号(S D actor registration mod RN)的立场文件 ule and of theSingle Reg istration Number (SRN) i n the Member States Registration of legacy de MDCG 2019-5 在 EUDAMED...
MDCG 2020-18 MDCG关于眼镜镜片和Ready阅读器UDI分配的立场文件.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2020-18 MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers December 2020 This document ha
MDCG 2020-3 重大变更和附件指南.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020 - 3 MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by cer
MDCG 2020-7_guidance_pmcf_plan_template_en
MDCG 指南清单2022年
MDCG 2020 -1 医疗设备软件的临床评价(MDR)和性能评估(IVDR)的解读.pdf,欧盟颁布MDCG文件指南,对医疗设备软件的临床评价(MDR)和性能评估 (IVDR)条款进行了进一步解读。 以下是指南的详细介绍: The purpose of this guidance is to provide a frameworkfor the determi
中英文对照 MDCG-2020-1 医疗器械软件的临床评价MDR 性能评价IVDR指南.pdf,MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2020-1 医疗器械协调小组文件 MDCG2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation(IVDR) ofMedi
mdcg_2020-2 rev1 第一类过渡条款 第120(3和4)章.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020-2 rev.1 MDCG 2020-2 rev. 1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020 July 2020 rev.1 This docume
【中文翻译】MDR 指南文件 MDCG 2020-6 已获得CE标记的MDD医疗设备所需的临床证据