EC REP
European Authorized Representative
EC REP (European Authorized Representative) is a legal entity established in the European Union appointed by a non-EU manufacturer to act on their behalf for regulatory matters under EU MDR.
Complete Guide to EC REP
An EC REP (European Authorized Representative), also called EUAR, is a natural or legal person established within the European Union who is appointed by a non-EU medical device manufacturer to act on their behalf for specific regulatory tasks under the EU Medical Device Regulation (MDR 2017/745).
Legal requirements:
- Mandatory for non-EU manufacturers selling in the EU
- Must be established within the EU (not EEA-only countries)
- Named on product label with EC REP symbol
- Registered in EUDAMED database
EC REP responsibilities (Article 11 EU MDR):
- Verify Declaration of Conformity and technical documentation exist
- Keep technical documentation available for authorities
- Cooperate with competent authorities on corrective actions
- Inform manufacturer of complaints and reports
- Terminate mandate if manufacturer doesn't comply
- Forward samples or access to devices to authorities
- Verify manufacturer has appropriate liability coverage
What EC REP does NOT do:
- Does not take over manufacturer's responsibilities
- Does not approve or certify devices
- Does not guarantee product quality
- Is not responsible for device design
Choosing an EC REP:
- Should have relevant medical device expertise
- Must have QMS for their AR activities
- Should have experience with your device type
- Consider their Notified Body relationships
Key difference from UK: Since Brexit, the UK requires a separate UK Responsible Person (UKRP) - an EC REP does not cover the UK market.
Related Terms
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An entity in the supply chain that makes medical devices available on the market without changing their intended purpose.
Any natural or legal person in the medical device supply chain who is involved in making devices available on the market, including manufacturers, authorized representatives, importers, and distributors.
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