EMA
歐洲藥品管理局
European Union
Last reviewed 2026-06-21
EMA在EU MDR 2017/745和IVDR 2017/746框架下協調歐盟醫療器材監管。雖然公告機構負責合格性評估，但EMA和歐盟委員會制定政策。從MDD到MDR的過渡從根本上重塑了27個歐盟成員國的器材監管。
器材分類
Class I, IIa, IIb, III
審批路徑
CE marking via Notified Body
核心監管職能
- ▸EU MDR/IVDR框架協調
- ▸EUDAMED資料庫監管
- ▸公告機構指定支持
- ▸CE標誌途徑
- ▸警戒和上市後監管
§ RELATED INTELLIGENCE
§ FAQ
What is EU MDR 2017/745?
EU MDR (Medical Device Regulation 2017/745) is the European Union's comprehensive framework for medical device regulation, replacing the older Medical Devices Directive (MDD 93/42/EEC). EU MDR introduced stricter clinical evidence requirements, enhanced post-market surveillance obligations, the EUDAMED database, and a new device classification system with four classes (I, IIa, IIb, III). The transition deadline has been extended to 2027-2028 for certain devices.
What is EUDAMED?
EUDAMED (European Database on Medical Devices) is the EU's centralized database for medical device information under EU MDR. It covers device registration, UDI/device identification, Notified Body certificates, clinical investigations, vigilance reporting, and market surveillance. EUDAMED aims to increase transparency by making certain device data publicly accessible.
What is the difference between MDD and MDR?
The MDD (Medical Devices Directive 93/42/EEC) was the previous EU regulatory framework. The MDR (Medical Device Regulation 2017/745) that replaced it introduced: stricter clinical evaluation and PMCF requirements, mandatory UDI (Unique Device Identification), enhanced scrutiny for high-risk devices, an Authorized Representative requirement, and the EUDAMED database. MDR is a regulation (directly applicable) rather than a directive (requiring national transposition).
How does CE marking work for medical devices?
CE marking indicates a medical device conforms to EU MDR requirements. For Class I devices, manufacturers can self-declare conformity. For Class IIa, IIb, and III devices, a Notified Body must conduct conformity assessment. The process involves: establishing a Quality Management System, preparing technical documentation, conducting clinical evaluation, and obtaining a CE certificate from the Notified Body.
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