EU-Authorized Representative
EU-Bevollmächtigter (German term)
Role required under MDR Article 11 for non-EU manufacturers — an EU-based person or organisation legally responsible for placing the device on the market.
Manufacturers established outside the EU may only place medical devices on the EU market once they have designated a single EU authorised representative (Article 11 MDR). The representative is the point of contact for authorities, keeps the technical documentation available, is registered in Eudamed and, under certain conditions, is liable together with the manufacturer. The role goes considerably further than the FDA’s U.S. Agent, whose remit is essentially a communication channel.
In practice in the German hospital market
In strict legal terms, an authorised representative in any EU member state is sufficient — but for German hospital listings, a German address with a German telephone number and German contacts is a de facto precondition. In MEX mandates, the German client GmbH takes on this role.
What the mandate must cover as a minimum
The basis is a written mandate that the authorised representative accepts. Under Article 11(3) MDR it obliges the representative at least to:
- verify that the EU declaration of conformity and the technical documentation have been drawn up and that the conformity assessment procedure has been carried out;
- keep copies of the technical documentation, the declaration of conformity and the certificates available to the authorities;
- comply with its own registration obligations and verify that the manufacturer has complied with its UDI and registration obligations;
- provide the authorities, on request, with all information and documentation in an official language of the member state;
- cooperate with the authorities on corrective and preventive action;
- forward complaints and reports from healthcare professionals or patients to the manufacturer immediately;
- terminate the mandate if the manufacturer acts contrary to its MDR obligations — and then inform the competent authority and the notified body.
The manufacturer’s own obligations — such as conformity assessment, the quality management system or the clinical evaluation — cannot be transferred to the representative through the mandate.
Liability
If the manufacturer has not complied with its obligations under Article 10 MDR, the authorised representative is legally liable for defective devices on the same basis as the manufacturer, jointly and severally with it (Article 11(5)). Since the MDR, the role is therefore no longer a mere mailbox. A serious authorised representative reviews a manufacturer’s documentation before accepting a mandate.
Authorised representative, importer, distributor — three roles
The MDR distinguishes three economic operators that are often confused by non-EU manufacturers:
| Role | Basis | Core task |
|---|---|---|
| EU authorised representative | Art. 11 | represents the manufacturer towards the authorities on regulatory matters |
| Importer | Art. 13 | places the device from a third country on the EU market for the first time; checks CE marking, registration and labelling |
| Distributor | Art. 14 | makes the device available on the market; checks labelling and accompanying documents |
One company can take on several of these roles. It then has to fulfil the obligations of each role separately and register in Eudamed once per role — each with its own SRN.
How MEX supports you
In our mandates, the authorised representative role and the PRRC sit in the German entity we set up and manage for you — together with registration in Eudamed, vigilance and communication with the authorities. Regulatory responsibility is thus located where hospital purchasing and sales take place.
Frequently asked questions
- Does the EU authorised representative have to be based in Germany?
- Not legally — establishment in any EU member state is sufficient. For listings in German hospitals, however, a German address and German-speaking contacts are a de facto precondition.
- Does the authorised representative appear on the label?
- Yes. For non-EU manufacturers, the name and address of the EU authorised representative are part of the device labelling (MDR Annex I, Section 23.2).
- Can I have more than one authorised representative?
- No. The MDR requires a single authorised representative per device. A change is possible, but under Article 12 MDR it must be agreed between the manufacturer, the outgoing and the incoming representative.