For a medical device manufacturer established outside the European Union, appointing an EU authorised representative (EC REP) is not a mere administrative formality — it is a condition of access to the European market.
Article 11 of Regulation (EU) 2017/745 (MDR) provides that a manufacturer not established in a Member State may only place its device on the Union market after appointing a single authorised representative. An equivalent requirement exists for in vitro diagnostic medical devices under the IVDR.
But as soon as a manufacturer starts requesting quotes, a difficulty appears: prices vary enormously and offers are rarely comparable at first glance.
One provider may quote a few hundred or a few thousand euros a year. Another charges per device. A third proposes an annual fee to which EUDAMED registration, mandate amendments, free sale certificates or certain regulatory interventions are then added.
So how much does an EU authorised representative really cost? The right answer is not a single figure. It depends above all on the service model chosen.
You can review our EU authorised representative service and its pricing to compare these models with an actual operational offer.
Why an EU authorised representative is not just an address in the EU
The first mistake is to treat the EC REP as a kind of “regulatory mailbox”. In the eyes of the regulation, its role is far more substantial.
The authorised representative must in particular verify that the EU declaration of conformity and the required technical documentation exist, keep certain documents available to the authorities, cooperate with the competent authorities, forward certain requests to the manufacturer, and act on vigilance and safety matters.
The regulation also provides for situations in which the authorised representative can be legally liable alongside the manufacturer where the latter fails to meet certain obligations.
That liability explains a significant part of the price of the service: the authorised representative is not merely selling administrative time. It is also accepting regulatory and legal exposure.
The level of risk attached to the manufacturer, its products and its organisation therefore naturally influences the commercial terms offered.
How much should you budget?
There is no official European price list. Prices are set freely by providers and vary according to the device class, the number of products or product families, the complexity of the portfolio, the level of support expected and the services included.
Although price transparency remains limited in this market, a few EU authorised representatives do publish indicative rates or packages covering different service levels. In 2026, the handful of publicly available prices show wide variations depending on the device class, the size of the portfolio and, above all, the services included in the mandate. Some offers start at around €1,600 for the first year, while more extensive packages can reach several thousand euros a year.
These figures should nonetheless be interpreted with caution. They do not come from any exhaustive market study and the offers are hard to compare: some correspond essentially to the representation mandate itself, while others include EUDAMED registration or support, document review, the handling of free sale certificates, or various regulatory support services.
It is therefore reasonable to treat these amounts as orders of magnitude, not as a market average. The real cost can be significantly higher for a large or complex portfolio, for high-risk devices, or where additional or premium regulatory services are built into the contract.
Ultimately, comparing the annual price alone is rarely meaningful.
The different types of offer
Model no. 1: an annual flat fee with a list of included devices. This is probably the easiest model to understand. The manufacturer pays a fixed sum each year for the representation service. Depending on the provider, the fee may cover one device, a device family, or a portfolio defined in the contract.
Model no. 2: a base fee + a price per device. This is also a very common model. The provider charges an annual base fee to represent the manufacturer, then adds an amount for each additional device or group of devices.
Model no. 3: a package with integrated regulatory services. Some authorised representatives take a broader approach. Regulatory representation is then bundled into a set of services that may include, for example:
- support with EUDAMED registration;
- review of certain regulatory documents;
- UDI support;
- assistance during exchanges with the authorities;
- certain steps relating to free sale certificates;
- regulatory monitoring.
The annual price may be higher, but the total cost can ultimately be more predictable. For a non-EU manufacturer without an experienced European regulatory team, this model can be particularly relevant.
Two professions must nonetheless be distinguished: being an authorised representative and being a regulatory consultant are not quite the same thing.
The real trap: extra fees
This is often where the real cost diverges from the advertised price.
A contract listed at €1,200 a year may look far cheaper than one at €2,000. But if the first provider bills each operation separately, the gap can quickly disappear.
The additional fees you may encounter include in particular:
- EUDAMED registration or support: some providers include it in their fee; others apply set-up or processing charges.
- Adding devices: pricing per device, family or group may be added to the annual fee.
- Amending the mandate: a change of address, company name or portfolio can generate administrative charges.
- Free sale certificate: preparing or processing a free sale certificate request may be a separate and sometimes significant service.
- Additional regulatory support: hours spent on a specific request from an authority, a vigilance issue or a substantial change may be billed separately.
The right question is therefore not “How much is your annual subscription?” but rather “What will my total cost be over three years in my real-world scenario?”
A serious comparison must be made over the duration of the mandate, not solely on the price advertised for the first year.
Since 2026, EUDAMED must also enter the equation
This question has become even more important as EUDAMED has ramped up. Since 28 May 2026, use of the first four functional EUDAMED modules has been mandatory: registration of economic operators, UDI/devices, notified bodies and certificates, and market surveillance.
For a manufacturer established outside the Union, the authorised representative also plays a role in its registration process as an actor.
You must therefore check that the quote clearly states what the provider does within EUDAMED and what remains the manufacturer’s responsibility. “EUDAMED support included” can mean very different things from one contract to another.
What you must absolutely avoid
1. Choosing on price alone. An abnormally low price should prompt close scrutiny of the scope of service. The authorised representative is an integral part of your European regulatory architecture. Saving a few hundred euros a year becomes secondary if the provider struggles to respond to authorities or has a poor command of your device category. You need to find the one whose business model matches your product portfolio.
2. Signing without understanding the extra fees. Ask for a complete price list before signing. Ideally it should cover foreseeable events: adding a product, amending the mandate, EUDAMED, free sale certificates, exceptional regulatory intervention and termination.
3. Accepting a vague definition of the number of devices. For manufacturers with a large portfolio, this is one of the main financial risks. The contract must state precisely the unit used for billing.
4. Overlooking the exit terms. Changing authorised representative is not like changing IT provider. The change can affect regulatory information, labelling, registrations and the associated documentation. Before signing, check the termination conditions, the notice period, any transfer fees and the cooperation expected with the incoming representative.
5. Confusing authorised representative, importer and distributor. These economic operators have distinct regulatory functions. The fact that an importer or a distributor is established in the Union does not automatically mean it fulfils the role of authorised representative within the meaning of the MDR or the IVDR. This distinction must be clear in your contractual and regulatory set-up.
Key takeaways
The cost of an EU authorised representative cannot be reduced to the amount of its annual fee. Behind sometimes very different prices lie billing models and, above all, service scopes that differ just as much. For a non-EU manufacturer, the issue is therefore less about finding the cheapest EC REP than about understanding precisely what is included, what will be billed on top, and how the cost will evolve with the device portfolio. EUDAMED, adding new products, requests from authorities, free sale certificates or the terms for changing representative can all significantly alter the bill. The comparison must therefore cover the total cost of the mandate over several years, but also the quality and breadth of the service offered. In European representation, an attractive price is only genuinely attractive if it matches the manufacturer’s regulatory needs and does not conceal an accumulation of extra fees.