欧盟医疗器械法规

UDI
MDCG 2024-14 Guidance on the implementation of the master UDI-DI solution for contact lenses
MDCG 2020-18 MDCG关于眼镜镜片和眼镜的UDI分配的立场文件
MDCG 2021-09 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
MDCG 2018-3修订版1 关于系统和程序包的UDI指导意见 
MDCG 2018-1 v4  关于基本UDI-DI和其变更的指导意见
MDCG 2019-1  关于基本UDI-DI发布实体运作的指导原则
MDCG 2019-2  将UDI规则应用到第745/2017号法规第1（8），1（9）和1（10）条提及的产品的设备部分的指南
MDCG 2018-4  系统或过程包的UDI核心元素的定义/说明和格式
MDCG 2018-5  医疗设备软件的UDI指导原则
MDCG 2018-6  澄清与医疗器械法规和体外医疗器械法规第16条有关的UDI相关责任
MDCG 2018-7  关于UDI数据库语言问题的临时注意事项
MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
IMDRF/UDI WG/N48 Final:2019 Unique device identification system (UDI system) application guide
MDCG 2021-11 Guidance on Implant Card - "Device types"
MDCG 2021-19 Guidance note integration of the UDI within an organisation's quality management system
MDCG 2022-7 Q & A on the unique device identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Commission Delegated Regulation (EU) 2023/2197 amending Regulation (EU) 2017/745 as regards the assignment of unique device identifiers for contact lenses

数据元素
Q&A Gradual roll-out of EUDAMED as amended by Regulation (EU) 2024/1860
MDCG 2020-15 关于在欧盟成员国中使用EUDAMED注册模块和单一注册号的文件
MDCG 2019-4  在EUDAMED中注册医疗器械数据的时间表
MDCG 2019-5  关于已上市的医疗器械在EUDAMED中注册指南
EUDAMED Actor模块常见问题解答 December 2020 v1.1
MDCG 2021-1 rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
2021/2078 Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed)
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

欧洲医疗器械命名法（EMDN）
MDCG 2024-2 Procedures for the updates of the European medical device nomenclature 
EMDN – EUDAMED中的使用术语:   01/2020
CND命名法–背景和基本原则:  01/2020
MDCG 2021-12 FAQ on European medical device nomenclature (EMDN)
MDCG 2018-2 将来的欧盟医疗器械术语-要求说明

Classification & Qualification
MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2022/2347 reclassification of groups of certain active products without an intended medical purpose
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products
MDCG 2021-24 Guidance on classification of medical devices
MDCG 2020-16 rev.3 在（EU）2017/746法规框架下体外诊断医疗器械分类规则指南
MDCG 2022-5 rev.1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
Manual (Ver.3-September 2023) on borderline and classification for medical devices and IVDs under MDR and IVDR
Helsinki Procedure (Version 23 June 2021) for borderline and classification under MDR/IVDR
MDCG 2019-11 软件的鉴定和分类

Post-market Surveillance
Regulation 2019/1020 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011
MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to Regulation (EU) 2017/745 (MDR)
MDCG 2023-3 rev.2 Q& A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2024-1 Device specific vigilance guidance (DSVG) template
MDCG 2024-1-5 Guidance on the vigilance system for CE-marked devices- DSVG 05 Urogynaecological surgical mesh implants used for pelvic organ prolapse repair and stress urinary incontinence
MDCG 2022-4 rev.2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

Clinical /Performance Investigation and Evaluation
MDCG 2024-15 Guidance on the publication of clinical investigation reports and their summaries in the absence of EUDAMED
MDCG 2024-10 Clinical evaluation of orphan medical devices 
MDCG 2024-5 Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
MDCG 2024-3 Guidance on content of the clinical investigation plan for clinical investigations of medical devices
2023/C163/06 Commission guidance on the content and structure of the summary of the clinical investigation report
MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR
2023/C163/06 Commission guidance on the content and structure of the summary of the clinical investigation report
MDCG 2022-20 Substantial modification of performance study under IVDR 
MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746  
MDCG 2020-13 临床评估考核报告模板 
MDCG 2020-10 / 1 临床试验中安全性报告指南 
MDCG 2020-10 / 2 附录：临床试验摘要安全性报告表 
MDCG 2020-8 关于使用PMCF评估报告模板的指南
MDCG 2020-7 关于使用PMCF计划模板指南 
MDCG 2020-6 有关已上市医疗器械的充分临床证据的指导意见
MDCG 2020-5 临床等效评估指南 
MDCG 2019-9 Rev.1 安全性和临床表现摘要 
MDCG 2022-9 rev.1 Summary of safety and performance template
MDCG 2021-6 rev.1 Regulation (EU) 2017/745 - Questions & Answers regarding clinical investigation 
MDCG 2021-8 Clinical investigation application/notification documents 
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations 
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation 
MDCG 2022-2 Guidance on general principles of clinical evidence for 体外诊断试剂， Diagnostic medical devices (IVDs) 
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)  
MDCG 2020-1  医疗设备软件临床评估/性能评估指南 
MDCG 2019-16 医疗设备网络安全指南

Standards
Summary of references of harmonised standards (9 Oct 2024) published in the Official Journal – Regulation (EU) 2017/745
Summary of references of harmonised standards (9 Oct 2024) published in the Official Journal – Regulation (EU) 2017/746
Regulation (EU) 2022/944 Rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices 
Commission Implementing Regulation (EU) 2023/1194 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
Commission Implementing Regulation (EU) 2022/2346 Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
MDCG 2021-5 rev.1 Guidance on standardisation for medical devices
IMDRF医疗器械标准目录 由于COVID-19进行了修订
Commission Implementing Decision (EU) 2021/1182 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745
Commission Implementing Decision (EU) 2022/6 Amending Implementing Decision (EU) 2021/1182 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745
Commission Implementing Decision (EU) 2021/1195 on the harmonised standards for 体外诊断试剂， diagnostic medical devices drafted in support of Regulation (EU) 2017/746
Commission Implementing Decision (EU) 2022/15 Amending Implementing Decision (EU) 2021/1195 on the harmonised standards for 体外诊断试剂， diagnostic medical devices drafted in support of Regulation (EU) 2017/746
2002/364 / EC 2002年5月7日委员会决定，针对 体外诊断试剂， 诊断医疗设备 
Commission Implementing Decision (EU)  C(2021) 2406 (M/575) on a standardisation request to the CEN and Cenelec as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Commission Implementing Regulation (EU) 2022/1107 Common specification for certain class D IVDs in accordance with Regulation (EU) 2017/746
Commission Implementing Regulation (EU) 2023/2713 Designating EU reference laboratories in the field of in vitro diagnostic medical devices

Specific 体外诊断试剂， diagnostic medical device guidance
MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
European Union reference laboratories (EURLs) in the field of in vitro diagnostic medical devices- Information pack for candidate laboratories
MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
MDCG 2021-14 Explanatory note on IVDR codes
MDCG 2021-4 rev.1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
MDCG 2021-22 rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
February 2022 Joint implementation and preparedness plan for Regulation (EU) 2017/746 on 体外诊断试剂， diagnostic medical devices (IVDR)
Regulation (EU) 2022/112 Amending Regulation (EU) 2017/746 as regards transitional provisions for certain 体外诊断试剂， diagnostic medical devices and the deferred application of conditions for in-house devices
MDCG 2022-3 Rev.1 Verification of manufactured class D IVDs by notified bodies
MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC 
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR 
Notice to Stakeholders: Status of the EU-Switzerland mutual recognition agreement (MRA) for in vitro diagnostic medical devices

COVID-19
MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical device
MDCG 2021-21 rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
COVID-19 TESTS Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19
2020年4月 关于COVID-19环境下的医疗设备，有源植入式医疗设备和体外诊断医疗设备的指南
2020年4月 用于COVID-19的3D打印和3D打印医疗产品的符合性评估程序
2020 / C122I / 01 Covid-19准则 体外诊断试剂， 诊断测试及其性能

其他指导条例
MDCG 2024-16 Manufacturer Information Form on interruption or discontinuation of supply of certain medical devices and certain IVDs (as per Art. 10a of Regulation 2024/1860)
Q&A Information obligation regarding interruption or discontinuation of supply of certain medical devices and IVDs as introduced by Regulation (EU) 2024/1860
MDCG 2023-4 guidance on medical device software (MDSW) intended to work in combination with hardware or hardware components
Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period acc. to Article 120, as amended by Regulation (EU) 2023/607
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 Extension of the MDR transitional period and removal of the "sell off" periods
MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Add 1. MDCG 2022-18 MDCG Position Paper on on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2021-3 Questions and answers on custom-made devices
MDCG 2020-9  呼吸机及相关配件的法规要求
MDCG 2019-3 v.1  关于医疗器械法规第54（2）b条的解释
MDCG 2020-2 rev.1  关于医疗器械法规第120条（3和4）– 第 I 类医疗器械的过渡规定
MDCG 2019-8 v2  关于植入体卡的指导文件
MDCG 2019-15, rev.1  第 I 类 医疗器械制造商的指导说明
MDCG 2019-07 rev.1  关于欧盟注册人（PRRC）的指南
SCHEER准则  某些医疗器械中邻苯二甲酸盐涉及致癌，诱变，生殖毒性（CMR）或具有内分泌干扰（ED）特性的风险评估指南，
CAMD CAMD MDR/IVDR Transition Subgroup: FAQ - MDR Transitional provision
MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
EMA Guidance Q & A for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the medical devices and in vitro diagnostic medical devices regulations (EU) 2017/745 and (EU) 2017/746
MDR/IVDR Language Requirements
MDCG 2021-25 Rev.1 Regulation (EU) 2017/745 - application of MDR requirements to legacy devices and to devices placed on the market prior to 26 May 2021 in accordance with AIMDD and MDD
MDCG 2021-26 Questions and answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
14 October 2021 Questions and answers on the progressive roll-out of the new in vitro diagnostic medical devices regulation
MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 
2021/2226 Commission implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices
COM(2022) 182 final Commission Report on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to EU MDR and EU IVDR

公告机构
MDCG 2024-12 CAPA plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams
MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR)
MDCG 2024-8 Preliminary assessment review (PAR) form template (IVDR)
MDCG 2024-7 Preliminary assessment review (PAR) form template (MDR)
MDCG 2024-6 Preliminary re-assessment review (PRAR) form template (MDR)
MDCG 2022-17 MDCG position paper on hybrid audits
MDCG 2022-14 Transition to the MDR and IVDR- Notified body capacity and availability of medical devices and IVDs
MDCG 2022-13 rev.1 Designation, re-assessment and notification of conformity assessment bodies and notified bodies
MDCG 2020-17 与MDCG 2020-4有关的问题和解答“关于在COVID-19隔离令和旅行限制期间，医疗器械公告机构审核临时特别措施指南”
MDCG 2020-14 针对公告机构在MDR / IVDR框架下进行监督审核中使用MDSAP审核报告的的指南
MDCG 2020-12 关于药械组合产品以及使用TSE易感动物组织制造的医疗器械向主管当局咨询的过渡指导原则
MDCG 2020-11  关于在医疗器械指令和有源植入式医疗器械指令下认证的公告机构续签指南   
MDCG 2020-4  关于在COVID-19隔离令和旅行限制期间，医疗器械公告机构审核临时特别措施指南
MDCG 2020-3 rev.1  关于MDD或AIMDD证书所涵盖的医疗设备在过渡阶段有重大变更时的指南
MDCG 2019-14  关于MDR代码的解释性说明
MDCG 2019-13  评估技术文件的设备采样指南
MDCG 2019-12  指定机构的最终评估表：关键信息
MDCG 2019-10 rev.1  根据指令签发的证书有效性的过渡性规定
MDCG 2019-6 v4  问题与解答：与公告机构有关的要求
MDCG 2018-8  证书内容以及自愿证书转让指南
NBOG BPG 2017-1  指定和通知符合性评估机构的最佳指南
NBOG BPG 2017-2  关于参与符合性评估人员所需信息的最佳实践指南
NBOG F 2017-1  符合性评估机构根据医疗器械法规申请指定为公告机构时应提交的申请表
NBOG F 2017-2  符合性评估机构根据体外诊断设备法规申请指定为公告机构时应提交的申请表
NBOG F 2017-3  符合性评估机构根据医疗器械法规申请指定和通知的范围
NBOG F 2017-4  符合性评估机构根据体外医疗器械法规申请指定和通知的范围
NBOG F 2017-5  初步评估审核模板（MDR）
NBOG F 2017-6  初步评估审核模板（IVDR）
NBOG F 2017-7  审查人员授权资格（MDR）
NBOG F 2017-8  审查人员授权资格（IVDR）
2017/2185/EU Commission Implementing Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of
the designation as notified bodies under MDR and IVDR

医疗器械单一审核程序 
MDSAP AU G0002.1.004  MDSAP配套文件
016 MDSAP常见问题

欧盟指导文件
2020年7月 防护设备符合性评估程序
2020年5月 如何验证医疗设备和个人防护设备是否可以合法地投放到欧盟市场上并由此进行购买和使用-同样适用于COVID-19环境下
2020年6月 医用口罩法规要求指南
2019/939 Commission Implementing Decision designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
2021/0323 (COD) Proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices