Choosing an EU Authorised Representative: 12 Questions to Ask First
Updated: Aug 30
There is no rating system for an EU authorised representative. No league table, no accreditation, no public register of who does the job well. Every provider signs the same mandate under the same article of the same regulation, and from the outside the offers look identical.
So the choice comes down to what you ask before you sign. Below are twelve questions, each tied to a specific provision. They are the questions we would ask if we were appointing someone else, and our own answers are at the end.
Before you appoint an EU authorised representative
1. What is your SRN?
An authorised representative must be registered in EUDAMED and holds a Single Registration Number. A provider that cannot give you one on request either is not registered or does not want you checking. The number should be verifiable in the public actor database in under a minute.
2. Who is your person responsible for regulatory compliance, and is that person employed by you?
Article 15(6) requires permanent and continuous availability. It does not require employment. The distinction matters on the day a competent authority asks a question. Ask which qualification route under Article 15(1) the person satisfies and how many manufacturers they cover.
3. Will you review my technical documentation before signing, or after?
Article 11(3)(a) requires the representative to verify that the declaration of conformity and technical documentation have been drawn up. A provider that signs first and reads later has agreed to a verification it has not performed.
4. Will you hold a copy of my technical documentation?
Article 11(3)(b) requires a copy to be kept available for competent authorities. Some providers interpret this as holding a pointer to the manufacturer rather than the documentation itself. Ask what is actually stored, where, and how quickly it can be produced.
What your EU authorised representative charges
5. How do you count devices?
This is where quotes stop being comparable. One provider counts each catalogue reference; another counts each Basic UDI-DI. If you sell one device in six sizes, that is a sixfold difference in fee for identical work. Ask how many Basic UDI-DIs your portfolio comes to under their counting, in writing.
6. What is included in the annual fee?
Routine EUDAMED submissions, regulatory change notifications, contact point duties — ask which of these are inside the fee and which are billed. The answer varies more than the headline price does.
7. What is charged separately?
Setup, mandate changes under Article 12, vigilance handling, additional device families, translations. None of these are unreasonable charges. All of them should be visible before you sign rather than after.
How your EU authorised representative performs
8. What is your response time to a competent authority?
The regulations set no fixed deadline for acknowledging an authority request, which makes any number you are given a service commitment rather than a legal one — and therefore worth having in the contract. Ask what happens outside working hours and during national holidays.
9. How many manufacturers does one person handle?
Representation is not passive. It involves reading regulatory updates against your specific devices, monitoring your registrations and responding when something changes. Capacity is a fair question and the answer tells you what kind of service you are buying.
10. Do you also act as importer or distributor for devices you represent?
There is no blanket prohibition, but concentrating roles concentrates risk. If one company represents you, imports your devices and distributes them, a single failure affects every link at once.
Leaving your EU authorised representative
11. What happens if I terminate?
Article 12 requires an agreement between you, the outgoing representative and the incoming one, covering termination and commencement dates and the transfer of documentation. Ask what happens to your file, what notice is required and whether any part of the annual fee is refunded.
12. Can I see the mandate before I commit?
Article 11(2) requires the mandate to be in writing and to cover at minimum the tasks in Article 11(3). A provider unwilling to show you the document before payment is telling you something. Read the termination clause, the liability clause and the scope of tasks.
What the answers usually reveal
Most providers answer eight or nine of these without difficulty. The ones that produce hesitation are consistently the same three: who the person responsible for regulatory compliance actually is, whether documentation is reviewed before signature, and how devices are counted for pricing.
Those three also determine what the relationship costs you and how it performs under pressure.
Our own answers
Publishing a list like this obliges us to answer it. In order.
• SRN: TR-AR-000057550 as authorised representative, TR-MF-000057496 as manufacturer, TR-IM-000056252 as importer. All three are in EUDAMED Production and publicly searchable.
• PRRC: a partner of the firm, with a deputy for continuity. The same person is responsible for regulatory compliance across our own device portfolio.
• Documentation review: before signature, as part of due diligence. Under Article 11(5) the liability is joint and several, which makes reading first a matter of self-interest as much as service.
• Storage: we keep the technical documentation itself, not a reference to it.
• Counting: one device equals one Basic UDI-DI. Unlimited UDI-DI variants under the same Basic UDI-DI are covered by the base fee.
• Included: routine EUDAMED submissions for the devices we represent, contact point duties, notification of regulatory changes affecting your registered devices, and ÜTS registration for the Turkish market.
• Separate: mandate changes under Article 12 and vigilance incident handling. Published on our pricing page.
• Response time: one business day for competent authority requests, 09:00–18:00 UTC+3, Monday to Friday.
• Capacity: deliberately limited. We would rather decline a portfolio than carry one we cannot monitor.
• Role concentration: we hold an importer registration for our own supply chain. We do not act as importer or distributor for devices we represent.
• Termination: handled under Article 12 with a tripartite agreement. Documentation transfers to the incoming representative in full.
• Mandate: sent on request, before any payment.
One more thing worth checking
Ask where the EU authorised representative is established, and what that means for the markets you want.
Under the EU–Türkiye Customs Union arrangement, an authorised representative may be nominated in Türkiye or in the Union, and a single appointment covers both markets. Both structures are lawful. What differs is execution: registration in ÜTS and correspondence with the Turkish authority are done locally or subcontracted.
If Türkiye is not on your roadmap this makes no difference. If it is, ask who does that work.
Sources
Regulation (EU) 2017/745, Articles 11, 12 and 15
Regulation (EU) 2017/746, Articles 11, 12 and 15
MDCG 2022-16 — guidance on authorised representatives
Notice to Stakeholders — EU-Türkiye Customs Union in the field of medical devices, European Commission, March 2022
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We publish our rates rather than quoting after a call. We are not a law firm and do not provide legal advice.
Our rates are published by class. EUDAMED submissions are part of the mandate rather than an extra, and ÜTS registration is available for manufacturers who also sell into Türkiye.
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