EC-REP for medical devices

Manufacturers without a seat in the European Union may place medical devices on the market there only if they appoint an authorised representative. Article 11 of the MDR describes the role: verifying that the declaration of conformity and technical documentation exist, keeping them available for the authorities, acting as contact point for enquiries, and cooperating on incidents and recalls. Their name and address appear on the labelling.

Decisive — and often underestimated — is liability. The authorised representative is jointly and severally liable with the manufacturer for defective devices where the manufacturer fails to meet its obligations. The role is therefore not a mailbox service: a serious representative reviews the documentation before signing and requires a mandate that clearly regulates access and termination rights.

For manufacturers and buyers alike, continuity and availability are worth checking. Changing representative means new labelling, new registration and notifications to the authorities. The providers listed here take on the role sometimes alone, sometimes together with registration, vigilance and the person responsible under Article 15.