How much does an EU authorised representative cost?

There is no single figure, because the price tracks the risk class of your devices, the number of generic device groups in the mandate and the retention tail attached to them. Providers that publish class-based annual pricing let you compare before enquiring; Medex publishes its own at /pricing. Treat any quotation that ignores class and portfolio breadth as incomplete rather than cheap.

Why do authorised representatives charge more for class III devices?

Because the work behind the same Article 11(3) duties is larger. Class IIa, IIb and III devices bring notified body certificates, amendments and supplements into the copy the representative must keep available, class IIb and III devices carry an annually updated PSUR, and Annex VI Part A requires additional registration data for those classes. Vigilance exposure also rises with class.

How long must an EU authorised representative keep my technical documentation?

Article 10(8) sets at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market, and at least 15 years for implantable devices. Annex IX Section 7 places the same period on the authorised representative where the manufacturer has no registered place of business in a Member State. The clock starts at last placement, not at mandate signature.

Is notified body assessment included in an authorised representative fee?

No. Conformity assessment is contracted directly between the manufacturer and the notified body, and is billed by that body under its own fee schedule. An authorised representative verifies under Article 11(3)(a) that an appropriate conformity assessment procedure has been carried out; it cannot perform, influence or price that assessment. Budget it as a separate line.

What does EUDAMED actor registration cost within the mandate?

Actor registration under Article 31 is normally inside the annual fee, because it is the representative's own obligation and produces its SRN. What is usually outside is preparing your device-side data — Basic UDI-DI, UDI-DI, EMDN and the Annex VI Part A device elements — which Articles 27 and 29 place on the manufacturer. If you want that done for you, expect a separate engagement.

What does it cost to change EU authorised representative?

The fee for the incoming mandate is usually the smallest part. Article 12 requires an agreement covering the date the outgoing representative may still appear in your information, so the real costs are label artwork, a reissued EU declaration of conformity, revised instructions for use, EUDAMED actor changes and any relabelling of stock already in the channel.

EU Authorised Representative Cost: What Drives the Price and What You Are Buying

Q: Can I split my portfolio between authorised representatives to lower the price?

Only across generic device groups. Article 11(1) requires a sole authorised representative, and MDCG 2022-16 reads that as one representative per generic device group. Different groups may go to different providers, but a single group cannot be divided. Whoever holds a group holds the whole of its Article 11(3) exposure, so price shopping within a group is not available.

6 days ago

7 min read

EU authorised representative cost is driven by four measurable things: the risk class of the devices under the mandate, the number of generic device groups it covers, the volume of vigilance and competent-authority correspondence the portfolio generates, and how long the representative must keep your documentation retrievable after the last unit is placed on the market. Everything else on a quotation is one of those four under a different name, or a service outside the Article 11 mandate altogether.

Regulation (EU) 2017/745 does not scale the representative's duties by class: Article 11(3) applies the same list to a class I thermometer and a class III implant. What scales is the work behind each duty.

What an EU authorised representative cost actually buys

The mandate is the product. Article 11(3) states that "The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers" — at least being a floor, not a ceiling. Those statutory tasks are what an annual fee must fund before anything optional is discussed; the mechanics are in our explainer on MDR Article 11 obligations.

Two consume time all year. The first is point (b), requiring the representative to "keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8)". The second is point (d): "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". Neither is a one-off onboarding task; both are standing capacity you rent.

Why risk class moves the EU authorised representative cost

Class is the strongest single pricing driver, for three reasons. First, the documentation set is bigger: a class I self-declared device generates a technical file and a declaration of conformity, while a class IIa, IIb or III device adds a notified body certificate with its amendments and supplements — all of which the representative must hold under point (b) — plus, under Annex IX Section 7, the decisions and reports of the notified body. Second, post-market output differs by class: class IIb and class III manufacturers must update the periodic safety update report "at least annually", class IIa "when necessary and at least every two years". Third, registration data is class-dependent — Annex VI Part A requires, for class IIa, IIb and III devices, the Member States where the device is or is to be made available.

Vigilance follows the same curve. Point (g) requires the representative to "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", and point (f) to cooperate with competent authorities on preventive or corrective action. A higher-class portfolio triggers both more often.

Retention outlives the relationship. Article 10(8) requires the documentation to be kept available for competent authorities "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", and adds: "In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market." Annex IX Section 7 puts the same clock on the manufacturer or, where it has no registered place of business in a Member State, its authorised representative: "for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market". The clock starts at last placement, not at signature: a device discontinued in year six still ties the representative to a readable copy for another decade.

What is normally included in the mandate fee

A properly scoped annual fee covers holding the mandate; the label, which under Annex I Section 23.2(d) must bear "the name of the authorised representative and address of the registered place of business of the authorised representative" where the manufacturer is established outside the Union; being named with its registered place of business in the EU declaration of conformity, as Annex IV point 1 requires; EUDAMED actor registration under Article 31 and upkeep of that record; forwarding competent authority requests; keeping the technical documentation copy retrievable; cooperating on corrective action; and handling vigilance correspondence both ways.

Actor upkeep is a recurring obligation: Article 31(4) requires that "Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30." Article 31(5) adds a periodic confirmation of accuracy. That is staffed capacity, not automation.

What is not included, and belongs on a separate budget line

The commonest budgeting mistake is assuming the fee absorbs work the Regulation leaves with the manufacturer — Article 11(4) bars the mandate from delegating the core Article 10 obligations:

Notified body conformity assessment fees. Charged by the notified body under its own contract with you; no authorised representative can perform or price that assessment.
Authorship of technical documentation. Drawing up Annex II and Annex III documentation is a manufacturer obligation; the representative verifies it exists and holds a copy, it does not write it.
Translation. Point (d) fixes the language of a competent authority response as the one that Member State determines, and Annex I requires the accompanying information in the languages each Member State requires. Translation scales with target markets, not with the mandate.
EUDAMED device registration data preparation. Point (c) requires the representative only 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". Preparing Basic UDI-DI, UDI-DI, EMDN and Annex VI Part A device data is yours, and having it done for you is a distinct engagement.
A PRRC for the manufacturer. Article 15(6) requires the representative to have a person responsible for regulatory compliance of its own, and MDCG 2022-16 states that person cannot also be the non-EU manufacturer's PRRC. Your own arrangement is a separate cost.
Distributor search and market entry. Not a regulatory function, and nothing to do with Article 11.

National fees sit outside any service price: Article 111(1) preserves the possibility for Member States to levy fees, "provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles".

Generic device groups: portfolio breadth as a pricing driver

Article 11(2) makes the mandate "effective at least for all devices of the same generic device group". That is why quotations are structured around generic device groups or product families rather than SKUs: forty variants inside one group are far less work than four devices across four groups, each with its own technical file, certificate history and vigilance stream.

It is also why EU authorised representative costs cannot be arbitraged within a group. Article 11(1) provides that "the device may only be placed on the Union market if the manufacturer designates a sole authorised representative", and MDCG 2022-16 reads that as one representative per generic device group. Different groups may go to different providers; a single group cannot be split between a cheap provider and a capable one.

The hidden costs of choosing badly

Three failure modes cost far more than the gap between two annual fees. The first is a representative that cannot produce documentation on request: point (d) allows no grace period, the failure surfaces in front of a competent authority, and the remedy is a market restriction, not a refund.

The second is a change of representative. Article 12 requires an agreement between the manufacturer, where practicable the outgoing representative and the incoming one, addressing "the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material". In practice: new label artwork, a reissued declaration of conformity, revised instructions for use, EUDAMED actor changes and possibly relabelled stock in the channel — costs that dwarf a year of fees. The mechanics are in our post on changing your authorised representative.

The third is a representative without its own PRRC. Article 15(6) requires an authorised representative to 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". A provider leaning on a nominal PRRC is one whose mandate you may have to unwind. If you are still shortlisting, see our guide to choosing an EU authorised representative.

Cost drivers and what to ask a candidate representative

Compare offers on substance.

Cost driver	Why it moves the price	What to ask the candidate
Risk class of the devices	Higher classes add certificates, amendments and Annex IX Section 7 reports to the copy held	Is your fee published by class, and what changes on up-classification?
Number of generic device groups	Article 11(2) fixes the mandate at group level; each group is a separate stream	How does your mandate define a group, and what triggers a new one?
Implantable devices in the range	Retention runs at least 15 years, not 10, after last placement	How do you fund and evidence retention after the mandate ends?
Expected vigilance volume	Points (f) and (g) require immediate forwarding and cooperation	What is your response time, and who covers it out of hours?
Language coverage	Point (d) fixes the response language as the one the Member State determines	Which languages do you handle in house, and what is charged?
EUDAMED actor upkeep	Article 31(4) requires updates within one week; Article 31(5) periodic confirmation	What is your SRN, and who maintains the actor record day to day?
PRRC arrangement	Article 15(6) requires one permanently and continuously available	Is the PRRC employed by you, and is there a named deputy?

Where Medex fits

Medex acts as an EU authorised representative under EUDAMED SRN TR-AR-000057550, with an in-house person responsible for regulatory compliance and a named deputy, and publishes class-based annual pricing at our pricing page rather than quoting per enquiry, so the EU authorised representative cost for your class is visible before you contact us. Medex does not carry out notified body conformity assessment, author clients' technical documentation or find local distributors; the scope covered is set out under our EU authorised representative service.