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類別: REGULATORY PATHWAYS
歐盟授權代表(EC REP)
由非歐盟製造商指定的在歐盟設立的法律實體，代表其進行EU MDR合規。EC REP必須標註在器材標籤上，負責註冊、警戒和監管溝通。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
EC REP (European Authorized Representative) is required when the manufacturer of a device placed on the EU market is not established in the Union. The EC REP is the primary contact for competent authorities on the manufacturer’s behalf.
PROCESS / STEPS
- Select an EC REP established in an EU Member State with capacity for vigilance and documentation access.
- Execute a written mandate defining tasks (MDR Art. 11 duties).
- Register the manufacturer and EC REP as economic operators (SRN) in EUDAMED when modules apply.
- Ensure labels and IFU include EC REP name and address as required.
- Maintain continuous access to technical documentation for NB and authority requests.
EXAMPLES
- US manufacturers exporting CE-marked devices to Germany/France must list an EU EC REP on labeling.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 歐盟授權代表(EC REP) across 27 authorities in real time.
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