Appoint an EU Authorised Representative

Appointing an authorised representative is a written act, not a form you tick. This page covers how to appoint Medex, what it costs, and what happens after signature. If you are still working out whether you need a representative at all, and what Article 11 asks of one, read the full guide at medexeurep.com/eu-rep/eu-authorized-representative.

Article 11(1) of MDR (EU) 2017/745 and IVDR (EU) 2017/746 requires a manufacturer without a registered place of business in a Member State to designate a sole authorised representative before placing a device on the EU market. Under Article 11(2) the designation is valid only once the representative accepts it in writing, and it is effective at least for all devices of the same generic device group.

How to appoint us

1. Send your device list. Give us the devices, their classification and their Basic UDI-DIs. You receive a written proposal at our published class-based rates. No sales call is needed to get a number.

2. Due diligence. We examine your technical documentation before the mandate is signed, not after a competent authority asks for it. This is also how we protect ourselves: under Article 11(5) we carry joint liability with you.

3. Signature. The obligations that transfer to us under Article 11(3), and the ones that stay with you under Article 11(4), are set out in writing before you sign.

4. Registration. We register as your authorised representative in EUDAMED and become your contact point for competent authorities.

What we do under the mandate

We verify that your EU declaration of conformity and technical documentation have been drawn up and that the appropriate conformity assessment procedure has been carried out. We keep a copy of your technical documentation permanently available for competent authorities, verify that your device registration obligations are met, and act as your contact point. We forward information requests, cooperate on preventive or corrective action, and pass on complaints and reports concerning your devices. These duties are set out in Article 11(3). Authority requests are acknowledged within one business day - that is our service commitment, not a statutory deadline.

What cannot be delegated

Article 11(4) draws a clear line. Device design, your quality management system and the drafting of technical documentation remain your responsibility as the manufacturer. No authorised representative can take these over, and any provider who offers to is misrepresenting the regulation. We are also not your importer, not your distributor, and not a notified body.

Shared liability

Under Article 11(5), if a manufacturer established outside the Union has not complied with its obligations, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. This is why we review documentation before accepting a mandate rather than after.

One appointment, valid in the EU and Türkiye

MDCG 2022-16 states that an authorised representative must be established within the Union. Türkiye sits inside that framework through the EU-Türkiye Customs Union: Decision 1/95 of the EC-Turkey Association Council, together with Decisions 2/97 and 1/2006, aligns Turkish medical device legislation with the Union acquis. The European Commission set out the consequence in its Notice to Stakeholders of March 2022: a manufacturer established outside both the EU and Türkiye designates only one authorised representative, either in Türkiye or in the Union.

Medex is established in Türkiye and registered in EUDAMED as an authorised representative under SRN TR-AR-000057550. The Article 11 mandate you sign with us is a single sole appointment and is valid on both sides of the Customs Union. One contract, one point of contact, one invoice.

This is an appointment, not a market-entry service. Placing a device on the Turkish market is done by an economic operator established in Türkiye, the importer or the distributor, which files the ÜTS registration from its own account. We do not act as importer or distributor, and we do not file ÜTS records on behalf of manufacturers established abroad.

If your own registered place of business is in Türkiye, you do not need an EU authorised representative at all. What you are likely to need instead is EUDAMED actor and device registration, UDI assignment, and representation for group companies established elsewhere. Ask us and we will tell you which of those applies to you.

Regulatory responsibility

Medex is registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, and as a manufacturer under SRN TR-MF-000057496. The people who maintain our own records will maintain yours.

What it costs

Annual representation starts at 800 EUR for Class I devices and Class A in vitro diagnostics, and runs to 2,000 EUR for Class III and Class D. Rates are per year, exclude VAT, and are fixed for three years from signature. There is no setup fee. Taking over an existing mandate under Article 12 costs 150 EUR. Our full rate card is published, so you can budget before you contact us.

Why our registered place of business is in Türkiye. Article 11(1) is a territorial test, so the question is a fair one: Medex Kurumsal is established in Ankara, not in a Member State. The answer is the EU–Türkiye Customs Union, and it comes from the Commission rather than from us. Its notice to stakeholders on the Customs Union agreement in the field of medical devices states: "manufacturers established outside the territory of the EU or Turkey only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." For the purposes of Decision No 1/95 of the EC–Turkey Association Council, territorial references in the Regulations are "understood to comprise the territory of the EU-Turkey Customs Union." MDCG 2022-16, the Commission guidance on authorised representatives, footnotes that notice where it defines the Union market.

In practice this is one mandate instead of two. Medex Kurumsal holds SRN TR-AR-000057550 in EUDAMED, and the same designation covers both sides of the Customs Union: the twenty-seven Member States and Türkiye. A representative established in a Member State covers the Union alone, so if Türkiye is also a market for you that would be a second appointment, a second contract and a second annual fee.

The limits matter as much as the scope. This mandate does not reach Switzerland, which requires a CH-REP established in Switzerland, and it does not reach Great Britain or Northern Ireland, where the MHRA requires a UK Responsible Person for Great Britain and a representative established in the EU or Northern Ireland for the Northern Ireland market. Those are separate appointments with separate territorial tests, and we say so before a mandate is signed rather than after.