EC REP
European Authorized Representative
EC REP (European Authorized Representative) is eine in der Europäischen Union ansässige juristische Person, die von einem Nicht-EU-Hersteller beauftragt wird, in regulatorischen Angelegenheiten gemäß EU-MDR in seinem Namen zu handeln.
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
More Local Representatives
View allEine von Nicht-EU-Herstellern benannte juristische Person, die in ihrem Namen für die Einhaltung der EU-MDR handelt und als Kontaktstelle zu den Regulierungsbehörden dient.
Eine brasilianische juristische Person, die erforderlich ist, um Medizinprodukteregistrierungen im Namen ausländischer Hersteller bei ANVISA zu halten.
Eine Einheit in der Lieferkette, die Medizinprodukte auf dem Markt bereitstellt, ohne deren Zweckbestimmung zu ändern.
Jede natürliche oder juristische Person in der Medizinprodukte-Lieferkette, die an der Bereitstellung von Produkten auf dem Markt beteiligt ist, einschließlich Hersteller, Bevollmächtigte, Importeure und Händler.
Need Help with EU Registration?
Pure Global provides regulatory consulting and AI-powered tools to help medical device companies navigate EU market access.