The European authorised representative is mandatory for any manufacturer outside the European Union that wants to place its devices on the European market. Article 11 of the MDR defines its framework. But in practice, this role is regularly reduced to a line on the label and an annual billing address. This is a mistake that can prove costly, both to the manufacturer and to the authorised representative.
What the EC REP is according to Article 11
The European authorised representative is a natural or legal person established within the European Union, designated in writing by the non-EU manufacturer to act on its behalf in relation to the manufacturer’s obligations arising from the MDR.
Two conditions are essential: a physical establishment within the EU (not a mailbox), and a written mandate defining the scope of responsibilities.
The obligations of the EC REP according to Article 11(3)
Article 11(3) lists the obligations assumed jointly by the manufacturer and its authorised representative. Jointly means that both can be held liable in the event of a failure.
EUDAMED registration. The EC REP creates and manages the manufacturer’s EUDAMED account, obtains the SRN, and registers the devices in the UDI/DEVICES module. For non-EU manufacturers, this is the only route of access to EUDAMED.
Regulatory point of contact. The EC REP is the point of contact for the national competent authorities of all EU Member States for any question relating to the manufacturer’s devices. In the event of a serious incident or a market surveillance investigation, it is the EC REP that receives requests for information and responds to them within the required deadlines.
Vigilance. The EC REP must verify that the manufacturer meets its obligations to report serious incidents and FSCA. It does not report in place of the manufacturer — but it is expected to ensure that the manufacturer does so correctly and within the deadlines.
Access to and retention of the technical documentation. The EC REP must be able to present the technical documentation at the request of the authorities. It must have guaranteed access to this documentation and retain it for the required periods (5 years for most devices, 10 years for implantable devices).
Mention on the label and in the declaration of conformity. The name and address of the EC REP must appear on the label of each device and in the EU declaration of conformity.
What the EC REP cannot do
Certify the devices. This role belongs exclusively to the designated notified body.
Draw up or validate the technical documentation. The technical documentation is the responsibility of the manufacturer. The EC REP can verify its existence and accessibility, not ensure its regulatory compliance.
Make regulatory decisions on behalf of the manufacturer without an explicit mandate. An EC REP that accepts obligations not covered by its contract exposes itself to liability without a corresponding means of action.
What this allocation implies for the contractual relationship
The mandate contract is the founding document of the EC REP / manufacturer relationship. It must precisely define: the devices covered, the responsibilities of each party, the arrangements for access to the technical documentation, the procedures in the event of a vigilance incident, and the conditions for termination. A vague contract is a source of disputes when a difficult situation arises — and in the field of medical device vigilance, difficult situations do arise.
Regulatory source: Article 11 of Regulation (EU) 2017/745 — EUR-Lex