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.
Our authorised representative registration in EUDAMED is 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. The registration is 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.
How it works
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Inquiry
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Review
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Mandate
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EUDAMED
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Representation
Regulatory responsibility
Article 15(6) requires an authorised representative to have permanent and continuous access to a person responsible for regulatory compliance. Ours is a partner of the firm, with a deputy for continuity.
Free tools and guides
Check the class of your device, find the deadline that applies to it and see what an authorised representative needs from you before you sign.
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EU authorised representative guide: what Article 11 requires, what the mandate covers and what it costs.
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MDR classification checker: the 22 rules of Annex VIII, with the rule text quoted.
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IVDR classification checker: the seven IVDR rules, classes A to D.
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MDR and IVDR transition deadline checker: which date applies to a legacy device.
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EU authorised representative FAQ: short answers to the questions manufacturers ask most.
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MDR and IVDR glossary: Article 2 definitions quoted in full.
Working with an EU Authorised Representative
A manufacturer based outside the EU needs one EU authorised representative before a device can be placed on the Union market. The questions below are the ones manufacturers ask most often when they choose an EU authorised representative for the first time.
When do you need an EU authorised representative?
If your company has no registered place of business in an EU Member State, the MDR and the IVDR require you to name a single EU authorised representative for your devices. The appointment is made through a written mandate, and it only takes effect once the EU authorised representative accepts it in writing.
One mandate covers at least all devices of the same generic device group, so a small product range rarely needs more than one EU authorised representative. Company size and device class do not change the requirement: being established outside the EU and Türkiye is the only trigger.
What the EU authorised representative checks
Article 11(3) sets the minimum tasks of every mandate. Before we sign, we verify that your EU declaration of conformity and technical documentation have been drawn up and that the right conformity assessment procedure was carried out. This is the first job of an EU authorised representative, and we do not skip it for low-risk devices.
After appointment, your EU authorised representative keeps the technical documentation, the declaration and any certificates available to competent authorities for the period the MDR sets. When an authority asks for samples or access to a device, the request is passed to you and its receipt is confirmed.
Complaints and reports of suspected incidents that reach your EU authorised representative are forwarded to you immediately. If corrective or preventive action is needed, we cooperate with the authority on your behalf and keep you informed at each step.
Liability and the limits of the mandate
Under Article 11(5), an EU authorised representative can be held jointly and severally liable with a non-EU manufacturer for defective devices where the manufacturer has not met its Article 10 obligations. That liability is the reason a careful EU authorised representative reviews your file before accepting the mandate, not after.
The mandate cannot move the manufacturer's core duties, such as the quality management system or post-market surveillance, to the EU authorised representative. If a manufacturer acts against its obligations, the EU authorised representative has to end the mandate and tell the competent authority, and the notified body where relevant, why it did so.
One EU authorised representative for the EU and Türkiye
Türkiye applies the MDR and the IVDR through the EU-Türkiye Customs Union. The European Commission's notice to stakeholders states that manufacturers established outside the EU or Türkiye only need one authorised representative, established either in the EU or in Türkiye.
Medex is established in Türkiye, so a single mandate with us gives you an EU authorised representative for the 27 Member States and for Türkiye. Our SRN as an EU authorised representative is TR-AR-000057550, and you can check it in the public EUDAMED actor search before you sign anything.
There are limits, and we state them at the start. Switzerland requires a Swiss representative, Great Britain a UK Responsible Person, and Northern Ireland a representative based in the EU or Northern Ireland. An EU authorised representative in Türkiye does not cover those markets.
Choosing an EU authorised representative
Fees differ from one provider to the next, but the useful comparison is what the EU authorised representative actually does for that fee. Ask who reviews your documentation, how quickly the EU authorised representative answers a competent authority, and whether the person responsible for regulatory compliance is on staff or outsourced.
At Medex, the person responsible for regulatory compliance is a partner of the firm, with a deputy for continuity. Our target is a reply to a competent authority within one day, because an EU authorised representative that answers late puts your devices at risk.
Our annual rates for each MDR and IVDR class are published on the pricing page, so you can compare EU authorised representative costs before you contact us.
Changing your EU authorised representative
Article 12 governs a change of authorised representative. The manufacturer, the outgoing EU authorised representative and the incoming one agree in writing on the end date of the old mandate, the start date of the new one and how documents and complaints pass between them.
We plan the switch with you so that EUDAMED, your labels and your technical documentation name the new EU authorised representative from the agreed date, without gaps in your records.
Devices we represent
We act as EU authorised representative for medical devices under the MDR and for in vitro diagnostic devices under the IVDR, from Class I and Class A products to devices that need a notified body.
Our guides cover device groups such as software, IVD reagents, wound dressings, dental devices and dermal fillers, and the same EU authorised representative mandate structure applies to each of them.
For Class I devices and Class A IVDs, where no notified body is involved, the review we carry out as your EU authorised representative is often the only independent look at the file before it reaches the market.
Manufacturers who already have an EU authorised representative and are unhappy with response times or document handling can move to us under the Article 12 procedure described above.
If you are not sure whether your product is a medical device at all, the free classification checkers linked above are a good first step before you appoint an EU authorised representative.
What we need to start
To act as your EU authorised representative we need your EU declaration of conformity, the technical documentation or access to it, notified body certificates where they apply, and your Basic UDI-DI data.
Once the file is complete, we sign the mandate and register the link in EUDAMED, and the EU authorised representative details can go on your labels and instructions for use.
If your device is also sold in Türkiye, the same team can handle ÜTS registration through your Turkish importer, so the information held by your EU authorised representative and your Turkish registration stay consistent.
The EU Authorised Representative Mandate, Clause by Clause
The mandate is the document that turns a service provider into your EU authorised representative. MDR Article 11 and IVDR Article 11 set the minimum it must contain, and a competent authority can ask to see it at any time. This is how we build each clause of an EU authorised representative mandate and why it matters to a non-EU manufacturer.
A written mandate the authority can read
Article 11(3) opens with a plain rule: "The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request." A mandate written in vague terms is therefore a risk for both sides, because the competent authority reads the mandate to see what your EU authorised representative has actually agreed to do.
Our mandate lists the devices covered by generic device group, names the manufacturer and the EU authorised representative with their SRNs, and sets out each Article 11(3) task in the wording of the Regulation. For in vitro diagnostic devices the mandate follows IVDR Article 11 in the same way, with the IVDR references in place of the MDR ones.
Registration duties written into the mandate
Point (c) of Article 11(3) requires the EU authorised representative to "comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29". In practice this means two separate checks: our own actor registration in EUDAMED, and your UDI assignment and device registration.
We check your Basic UDI-DI and device data before we confirm the mandate in EUDAMED, so that the EUDAMED registration of the device and the mandate refer to the same devices.
Answering a competent authority
Point (d) is the clause that is tested most often. The EU authorised representative must, "in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned".
That is why the mandate gives us standing access to the current technical documentation and the EU declaration of conformity, not a copy that was frozen on the day of signature. An EU authorised representative cannot answer an authority with documents it does not hold.
Samples, complaints and incidents
Under point (e), the EU authorised representative must "forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device".
Under point (g), it must "immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated". Our mandate names one contact on your side for these messages, so that a complaint received by your EU authorised representative reaches the right person without delay.
Termination and the competent authority
Point (h) obliges the EU authorised representative to "terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation". Article 11(6) then requires the representative to "immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor".
We explain this clause before signature. A non-EU manufacturer should know exactly when its EU authorised representative is required to step away, and the mandate states the steps we take before it comes to that.
Which competent authority is yours
Article 11(7) settles a question many non-EU manufacturers ask: "Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business."
In other words, the location of your EU authorised representative decides which competent authority treats you as its manufacturer. With Medex, established in Türkiye under the EU-Türkiye Customs Union, the mandate states this clearly so that there is no doubt about the competent authority that oversees the EU authorised representative relationship.
Importers, the PRRC and Your EU Authorised Representative
A non-EU manufacturer selling in Europe usually works with three parties at once: an EU authorised representative, one or more importers, and a person responsible for regulatory compliance. The MDR gives each a different role. Knowing where those roles meet prevents duplicated work and gaps that a competent authority would notice.
What the importer checks about your EU authorised representative
Before an importer places your device on the market, Article 13(2)(b) requires it to verify that "a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer". An importer cannot complete its own checks without a valid mandate in place, so appointing the EU authorised representative is normally the first step in an EU launch.
Importers also have to verify the EUDAMED registration of the device and add their own details to it, as Article 13(4) sets out. We share the mandate details and SRN of your EU authorised representative with each importer you name, so that their checks go through without repeated requests.
Information that flows back to the EU authorised representative
The importer is required to inform the representative as well as the manufacturer. Under Article 13(7), importers who believe a device is not in conformity "shall immediately inform the manufacturer and its authorised representative". Under Article 13(8), complaints and reports about suspected incidents received by an importer must be forwarded "to the manufacturer and its authorised representative".
Your EU authorised representative therefore receives information from several directions. We log every message received under the mandate and pass it to your nominated contact, so that nothing reported by an importer is left with your EU authorised representative alone.
The PRRC of an EU authorised representative
Article 15(6) sets a separate requirement for the representative itself: "Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union."
This PRRC belongs to the EU authorised representative and is different from the PRRC the manufacturer must have under Article 15(1). Your own PRRC remains your responsibility; ours supports the tasks of the mandate and the contact with competent authorities.
Importers in Türkiye and ÜTS registration
Under the EU-Türkiye Customs Union, an EU authorised representative established in Türkiye covers both markets for the same devices. Devices sold in Türkiye also have to be registered in ÜTS, the Turkish product tracking system, by the company that places them on the Turkish market.
Medex prepares that ÜTS registration for your Turkish importer as ÜTS registration consultancy, using the same declaration of conformity, technical documentation and Basic UDI-DI data that your EU authorised representative already holds. One file serves the mandate, the EUDAMED registration and the ÜTS records.
Changing representative without losing the record
When a manufacturer moves to a new EU authorised representative, Article 12(d) keeps the old one involved for a time: the agreement must cover "the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative".
As the incoming EU authorised representative, we request this clause in writing and update the EUDAMED registration, the label text and the importer records on the agreed date, so that every party knows which EU authorised representative to contact.
EU Authorised Representative for MDR and IVDR Devices
MDR DEVICES
Class I to Class III
For self-certified Class I devices, your EU authorised representative checks the EU declaration of conformity and the technical documentation against Annexes II and III of the MDR.
For Class Is, Im and Ir devices and for Class IIa, IIb and III devices, it also confirms that the notified body certificate covers every device named in the mandate.
IVDR DEVICES
Class A to Class D
Under the IVDR, non-sterile Class A devices are self-certified, while sterile Class A, Class B, Class C and Class D devices involve a notified body.
Your EU authorised representative reviews the performance evaluation, the declaration of conformity and, where required, the certificate before the mandate is signed.
SOFTWARE
Medical device software
Software with a medical purpose is a device in its own right, and the same EU authorised representative mandate applies to it.
Rule 11 of Annex VIII often places software in Class IIa or higher, so we check that the certificate and the declaration of conformity cover each software version placed on the Union market.
The same Article 11 framework applies to medical devices under the MDR and to in vitro diagnostic medical devices under the IVDR. What changes from one device type to another is the documentation your EU authorised representative reviews and the notified body evidence it checks before accepting the mandate.
Before, During and After the EU Authorised Representative Mandate
BEFORE SIGNATURE
Due diligence on your file
Article 11(3)(a) requires the EU authorised representative to "verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer".
We list any gaps in writing so that your team can close them before the mandate is accepted.
DURING THE MANDATE
Authority contact and records
While the mandate runs, your EU authorised representative holds the declaration, the technical documentation and the certificates for competent authorities, answers their requests and forwards complaints and incident reports.
It also keeps the EUDAMED registration accurate, and you are copied on correspondence sent under the mandate.
AT THE END
A documented handover
A mandate ends by agreement, by a change of representative under Article 12 or by termination under Article 11(3)(h).
In each case the EU authorised representative hands over the file, updates EUDAMED and, where Article 12 applies, keeps forwarding complaints about the devices it represented, so the competent authority sees a complete record.
An EU authorised representative mandate has three stages, and each stage carries its own obligations under the MDR and the IVDR. A non-EU manufacturer that knows what happens at each stage can plan its EU launch, its EUDAMED registration and its labelling around them.
What Your EU Authorised Representative Keeps on File
DECLARATION
EU declaration of conformity
The current EU declaration of conformity for every device in the mandate, with each revision kept.
Your EU authorised representative checks that the declaration names the right device, class and SRN before it is filed.
DOCUMENTATION
Technical documentation
Article 10(8) requires a non-EU manufacturer to "ensure that the authorised representative has the necessary documentation permanently available".
We hold the technical documentation, or secure access to it, for the period the MDR sets.
RETENTION
The period that applies
The documents stay available "for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market".
For implantable devices the MDR sets a longer period of at least 15 years.
Article 10(8) and Article 11(3)(b) together decide which documents an EU authorised representative must be able to produce for a competent authority, and for how long. Each record below stays available to the authorities for the full retention period, not only while sales continue.