EU Authorised Representative

Every authorised representative signs the same Article 11 mandate and carries the same obligations. What differs is execution: whether the technical documentation is read during due diligence or after an authority asks for it, whether the person responsible for regulatory compliance sits inside the firm or is retained by contract, and whether competent authority correspondence is answered by the people who signed the mandate or passed to a subcontractor.

We hold manufacturer, importer and authorised representative registrations in EUDAMED and file UDI records for our own devices. All three are publicly searchable.

Article 11(1) of the MDR leaves no room: where the manufacturer of a device is not established in a Member State, "the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." IVDR Article 11(1) says the same for in vitro diagnostics. There is no class threshold and no grace period. The appointment also only exists once it is accepted: under Article 11(2) the designation "shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group."

Under Article 11(3) we verify that your EU declaration of conformity and technical documentation have been drawn up, keep a copy available to competent authorities, meet the EUDAMED registration obligations in Article 31, respond to authority requests in the official Union language the Member State determines, forward requests for samples or access to a device, cooperate on preventive and corrective action, and pass on complaints and suspected incidents. Article 11(4) draws the other half of the line: device design, your quality management system and the drafting of the technical documentation stay with you. No representative can take those over, and any provider who offers to is misreading the Regulation.

We read the file before we sign because Article 11(5) makes the exposure ours as well as yours: where a manufacturer established outside the Union has not complied with Article 10, the authorised representative is "legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." That is why our due diligence happens before signature rather than after a question arrives from an authority.

One appointment covers both sides of the EU-Türkiye Customs Union. Medex is established in Türkiye and registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, as a manufacturer under TR-MF-000057496 and as an importer under TR-IM-000056252. All three are searchable in the EUDAMED public actor database without asking us for anything.

Rates are published rather than quoted after a sales call: from EUR 800 a year for Class I and Class A, up to EUR 2,000 for Class III and Class D, no setup fee, and EUR 150 for an Article 12 change of representative.