MDCG 2021-8：临床调查申请/通知文件
文件编号：MDCG 2021-8
发布日期：2021年5月
适用法规：EU MDR 2017/745
官方PDF：下载
文件目的
本文件提供了临床调查申请（须主管机构批准）和通知（无需批准）的标准文件清单，帮助申办方准备完整的申请包。
申请与通知的区别
| 情形 | 程序类型 | 法规依据 |
|---|---|---|
| 植入式器械或III类器械的临床调查 | 申请（须批准） | 第62(4)条 |
| 其他器械的临床调查 | 通知（无需批准，30天等待期） | 第74(1)条 |
| PMCF研究（涉及额外程序） | 通知 | 第74(2)条 |
申请文件清单
必须提交的文件
行政文件：
- [ ] 申请表（含申办方信息、器械信息、调查概述）
- [ ] 申办方授权书（若申办方与制造商不同）
- [ ] 主要研究者资质证明
器械文件：
- [ ] 器械描述（含技术规格）
- [ ] 制造商声明（器械符合GSPR，临床性能除外）
- [ ] 标签和说明书草案
- [ ] 技术文件摘要（设计、制造、预期目的）
临床调查文件：
- [ ] 临床调查计划（CIP）
- [ ] 研究者手册（IB）
- [ ] 知情同意书（含患者信息表）
- [ ] 病例报告表（CRF）草案
伦理和保险：
- [ ] 伦理委员会意见（若已获得）
- [ ] 保险证明（受试者伤害赔偿）
统计文件：
- [ ] 统计分析计划（SAP）或CIP中的统计部分
可选文件（视情况）
- 已有临床数据摘要（若有）
- 临床前数据摘要（若相关）
- 数据监察委员会（DSMB）章程（若设立）
通知文件清单
通知文件与申请文件基本相同，但：
- 无需等待主管机构批准（30天等待期后可开始）
- 须在EUDAMED中注册（EUDAMED完全运行后）
文件格式要求
- 文件须以调查所在成员国接受的语言提交
- 通常须提供英文版本（便于跨成员国协调）
- 电子提交格式须符合成员国要求
相关文件
官方文件全文
MDCG 2021-08
Clinical investigation application/notification documents
May 2021
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 a representative of the European Commission chairs it. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
Medical Devices Coordination Group Document MDCG 2021-08
Acronyms
| EUDAMED | European database on medical devices |
|---|---|
| GSPR | General safety and performance requirements |
| NCA | National Competent Authority |
| PMCF | Post-market clinical follow-up |
| REC | Research ethics committee |
Introduction
The sponsor of a clinical investigation is required to submit an application/notification 1 to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV of Regulation (EU) 2017/745 (MDR). 2 The application/notification is required to be submitted by means of the electronic system referred to in Article 73 of the MDR.
In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR.
These documents include:
- Clinical investigation - application/notification form under the MDR
- Addendum to the clinical investigation application/notification form for:
- Additional investigational device(s) (section 3)
- Additional comparator device(s) (section 4)
- Additional investigation site(s) (section 5)
- Clinical investigation supporting documents - Appendix of documents to attach
- Checklist of general safety and performance requirements, Standards, common specifications and scientific advice
Insofar as possible, the clinical investigation application/notification form includes same data fields to the EUDAMED system in development.
For further guidance with respect to the application of certain MDR provisions during the absence of EUDAMED please see MDCG 2021-1 Rev.1. 3 In the absence of EUDAMED, the Union-wide unique single identification number for a clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation will be the CIV-ID which is currently used for Eudamed2, the electronic system which supports the medical device Directives. 4
Use of templates
These documents are intended to be facilitative and their use by the Competent Authorities and sponsors is encouraged, however it is important to check with the individual Member State in which the clinical investigation is planned to be conducted as to any specific national requirements. It is planned that these templates will be withdrawn once the EUDAMED module for clinical investigations is fully functional. Further operational guidance with respect to the use of the guidance may be provided in due course.
Annex - Templates
| Title | Document |
|---|---|
| Clinical investigation - application/notification form under the Medical Device Regulation | Clinical investigation_notificat |
| Additional investigational device(s) (section 3) | Section 3 - Additional investigational device( |
| Additional comparator device(s) (section 4) | Section 4 - Additional comparator device(s). |
| Additional investigation site(s) (section 5) | Section 5 - Additional investigation site(s).pd |
| Clinical investigation supporting documents - Appendix of documents to attach | CI supporting documents - appendix |
| Checklist of general safety and performance requirements, Standards, common specifications and scientific advice | GSPR and list of standards applied.doc |
Footnotes
- Clinical investigation application (MDR Art. 62(1)), PMCF investigation notification (MDR Art. 74(1)), other clinical investigation application/notification, i.e. a national application (MDR Art. 82(1)).
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017, p. 1-175.
- MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional, May 2021.
- Council Directives 90/385/EEC and 93/42/EEC.