标准简介
欧盟医疗器械法规（EU MDR）2017/745 是管理投放欧盟市场的医疗器械安全性和性能的综合法规框架。该法规取代了之前的医疗器械指令（MDD 93/42/EEC），于 2021 年 5 月 26 日全面适用，代表了欧盟医疗器械监管的根本性改革。MDR 引入了更严格的临床证据、上市后监督、风险管理和通过唯一器械标识（UDI）实现可追溯性的要求。它适用于从简单绷带（I 类）到维持生命的植入物（III 类）的医疗器械，涵盖欧盟市场上约 50 万种类型的医疗器械。
MDR 合规要求制造商实施质量管理体系（通常为 ISO 13485），准备全面的技术文件，进行具有充分临床证据的临床评价，建立包括定期安全更新报告（PSUR）在内的上市后监督系统，为器械分配 UDI 编码，在 EUDAMED 数据库中注册，并通过符合性评估获得 CE 标志。较高风险的器械（IIa、IIb、III 类）需要公告机构的参与——这些经认可的组织审核和认证器械合规性。从 MDD 到 MDR 的过渡已多次延长，某些器械类别的最终截止日期延至 2027-2028 年。该法规还引入了高风险器械的新审查程序、III 类植入物的强制临床调查，以及法规合规负责人（PRRC）的概念。
Risk-Based Classification
Classifies medical devices into Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk), with increasingly stringent conformity assessment requirements.
Unique Device Identification
Requires a Unique Device Identification (UDI) system for traceability. Devices must be registered in the European Database on Medical Devices (EUDAMED).
Clinical Evidence
Mandates clinical evaluation for all devices. Higher-risk devices typically require clinical investigations. Post-market clinical follow-up (PMCF) is mandatory for all classes.
list_alt Key Obligations
- Device classification (Rule 1-22 in Annex VIII)
- Quality Management System (ISO 13485)
- Clinical evaluation and clinical investigations
- Technical documentation per Annexes II and III
- Unique Device Identification (UDI-DI and UDI-PI)
- Post-market surveillance and PMCF
- Serious incident reporting (vigilance)
- Notified Body conformity assessment for Class IIa+
Who Needs to Comply?
Manufacturers of medical devices placed on the EU market, including authorized representatives for non-EU manufacturers. Covers a vast range of products from bandages to implants, surgical instruments, and in-vitro diagnostic accessories.
Key Requirements
Device Classification
Classify your medical device using the 22 classification rules in Annex VIII. Classification determines the conformity assessment route, clinical evidence requirements, and Notified Body involvement.
Technical Documentation
Prepare comprehensive technical documentation per Annex II (device description, design, manufacturing, risk management, clinical evaluation, labeling) and Annex III (post-market surveillance plan).
Clinical Evaluation
Conduct and document a clinical evaluation per Article 61 and Annex XIV. Demonstrate safety and performance through clinical data — literature review, clinical experience, and/or clinical investigations.
Post-Market Surveillance
Establish a post-market surveillance system proportionate to device risk class. Conduct post-market clinical follow-up (PMCF). Report serious incidents to competent authorities within 15 days (or 10/2 for trends/serious threats).
EUDAMED Registration
Register as an economic operator, register devices with UDI codes, submit safety and clinical data, and report vigilance data through the European Database on Medical Devices (EUDAMED).
Penalties & Enforcement
Non-compliant devices are withdrawn from the EU market. Member states can impose fines (e.g., up to EUR 500,000 in Ireland). Criminal sanctions apply in some member states. Notified Bodies can suspend or withdraw CE certificates.