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.