EMA
欧洲药品管理局
European Union
Last reviewed 2026-06-21
EMA在EU MDR 2017/745和IVDR 2017/746框架下协调欧盟医疗器械监管。虽然公告机构负责合格性评估，但EMA和欧盟委员会制定政策。从MDD到MDR的过渡从根本上重塑了27个欧盟成员国的器械监管。
器械分类
Class I, IIa, IIb, III
审批路径
CE marking via Notified Body
核心监管职能
- ▸EU MDR/IVDR框架协调
- ▸EUDAMED数据库监管
- ▸公告机构指定支持
- ▸CE标志途径
- ▸警戒和上市后监管
§ 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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