2020年6月,MDCG 发布了MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured usingtransmissible spongifor...
MDCG 2022-16(二零二零年10月)Guidance on Authorised Representatives Regulation (EU) 2017745 and Regulation EU)2017746.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2022-16 MDCG 2022-16 Guidance on Authorised Representatives Regulat
1.首先登录链接:医械云平台(mdcpp.com),点击左上角“分类数据库”中的“国际法规”,如图: 2.进入页面,在搜索框中搜索指南标题,例如:MDCG 2023-7 - Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR - December 2023,点击下载或者根据提示...
内容提示: Medical Devices 医疗器械 Medical Device Coordination Group Document MDCG 2022 – 5 医疗仪器统筹小组文件 mdcg2022-5 MDCG 2022 – 5 MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices 根据《2017/745 医疗...
2021年10月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2021-24 医疗器械分类指南”(Guidance on classification ofmedical devices)。该文件的结构与MDD分类指南(MEDDEV 2.4/1)的结构非常相似:第一部分描述了适用于正确分类的一般原则,随后是一系列流程图,提供了分类规则的可视化表示,并通过示例提供了每一...
guidanceoncontentoftheInvestigator’sBrochurefor clinicalinvestigationsofmedicaldevices April2024 ThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup(MDCG) establishedbyArticle103ofRegulation(EU)2017/745.TheMDCGiscomposedof representativesofallMemberStatesanditischairedbyarepresentativeoftheEuropean ...
MDCG Provides Roadmap for MDR Device Transition An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market. READ MORE Categories Art...
Section F. Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s) ... 11 Section G. – Estimated date of the PMCF evaluation report ... 12 第4页 Medical Device Medical Device Coordination ...
MDCG 2019-7 guidance on PRRC 翻译中文+英文 下载积分: 1000 内容提示: MDCG 2019-7 中文 1 / 5 MDCG 2019-7 关于医疗器械 法规( (MDR )和体外诊断 试剂法规( (IVDR )第 15 条关于 " 合规 负责人 人"person responsible for regulatory compliance (PRRC) ) 的指南 制造商1 (第 1 段) 制造...
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Artic