What an EU Authorized Representative does
Under the EU Medical Device Regulation (MDR, Art. 11), a manufacturer without a registered place of business in the EU must appoint an authorized representative (EC-REP) established in the Union. This representative is the link between manufacturer, authorities and the market.
Your advantages
- A fixed point of contact in the EU with an address for service.
- Receipt of authority requests and communication in the local language.
- Keeping the technical documentation available and support with EUDAMED.
- Involvement in vigilance reports and corrective actions.
The process
- Initial consultation: clarify product category, risk class and existing certificates.
- Review: examination of the technical documentation and conformity evidence.
- Mandate: representation agreement and appointment as EC-REP.
- Operation: registration, ongoing representation and communication with authorities.