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CATEGORY: REGULATORY PATHWAYS
EC REP (European Commission Representative)
A legal entity established in the EU designated by a non-EU manufacturer to act on their behalf for EU MDR compliance. The EC REP must be named on device labeling and is responsible for registration, vigilance, and regulatory communication.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 EC REP (European Commission Representative) across 27 authorities in real time.
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