標準簡介
歐盟醫療器材法規（EU MDR）2017/745 是管理投放歐盟市場的醫療器材安全性和性能的綜合法規框架。該法規取代了之前的醫療器材指令（MDD 93/42/EEC），於 2021 年 5 月 26 日全面適用，代表了歐盟醫療器材監管的根本性改革。MDR 引入了更嚴格的臨床證據、上市後監督、風險管理和透過唯一器材標識（UDI）實現可追溯性的要求。它適用於從簡單繃帶（I 類）到維持生命的植入物（III 類）的醫療器材，涵蓋歐盟市場上約 50 萬種類型的醫療器材。
MDR 合規要求製造商實施品質管理系統（通常為 ISO 13485），準備全面的技術文件，進行具有充分臨床證據的臨床評價，建立包括定期安全更新報告（PSUR）在內的上市後監督系統，為器材分配 UDI 編碼，在 EUDAMED 資料庫中註冊，並透過符合性評估取得 CE 標誌。較高風險的器材（IIa、IIb、III 類）需要公告機構的參與——這些經認可的組織稽核和認證器材合規性。從 MDD 到 MDR 的過渡已多次延長，某些器材類別的最終截止日期延至 2027-2028 年。該法規還引入了高風險器材的新審查程序、III 類植入物的強制臨床調查，以及法規合規負責人（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.