The following terms are used as defined in the Medical Device Regulation (EU) 2017/745 (MDR): 医疗器械法规(EU)2017/745(MDR)中定义了以下术语: l‘performance’; l 性能 l‘risk’; l 风险 l‘intended purpose’ l 预期用途 l‘benefit-risk determination’; l 受益风险决定 l‘clinical evaluation...
2022年12月16日,欧盟医疗器械协调小组发布了第21份指南,MDCG 2022-21 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (E... 指南 MDCG 文章 MDCG更新欧盟医疗器械边界和分类手册2.0版本 欧洲时间2022年12月15日,MDCG小组发布了MDR和IVDR下的边界分类手册第二版,这是在今年9月...
篇1 The European Union Medical Device Regulation (MDR) provides a comprehensive regulatory framework to ensure the safety and effectiveness of medical devices marketed in the EU. The MDR replaces the existing Medical Device Directive (MDD) and introduces several new requirements to enhance the ...
欧盟mdcg医疗器械法规中英文对照 EU MDR/IVDR Regulations - Key Changes and Impacts on Medical Device Manufacturers Introduction:The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) represent a major overhaul of the regulatory framework for medical...
It is one of several means intended to fulfil the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information. SSCP旨在为公众提供关于医疗器械最新临床数据以及除医疗器械安全性和临床性能以外的其他信息。SSCP是预期用户的一个重要信息来源——无论是...
关于Regulation(EU)2017/746下 体外诊断医疗器械分类规则的指导 2024年7月 本文件已获Regulation(EU)2017/745第103条设立的MedicalDeviceCoordination Group(MDCG)认可。 MDCG由所有成员国代表组成,并由欧洲委员会一名代表担任主席。本文件并非欧洲 委员会官方文件,不反映欧洲委员会的正式立场。本文件中表达的观点不具...
mdcg_2021-25 MDD传统设备用于MDR的要求.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2021-25 MDCG 2021-25 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 2
Another important change introduced by the MDR is the requirement for manufacturers to demonstrate compliance with a set of common specifications called Medical Device Coordination Group (MDCG) guidelines. These guidelines cover various aspects of medical device regulation, including clinical evaluation, cla...
MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2021-5Rev.1 1.EUlegislationonmedicaldeviceswithinthe“NewApproach”andthe “NewLegislativeFramework” 1 TheEUlegislativeframeworkonmedicaldevicescurrentlyconsistsoftwoRegulations, adoptedandenteredintoforcein2017: •Regulation(EU)2017/745onmedicaldevices2(MDR...
between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices 根据《2017/745 医疗仪器规例》(欧盟)就医疗仪器与药物之间的界线提供指引 April 2022 二零二二年四月 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 1...