Every non-EU device maker needs an EU Authorised Representative, and every AR needs a PRRC. Prices range from a few hundred euros to several thousand a year — here is what drives the number, what is usually extra, and how to spot a representative that will cost you more later.
A non-EU manufacturer of medical devices or IVDs must appoint one EU Authorised Representative (MDR/IVDR Art. 11), and needs a PRRC (Art. 15) — its own, plus the one the AR must have. Published rate cards in 2026 put an AR at roughly EUR 800–2,500 a year for a class I device and EUR 1,500–5,500 for class III, with set-up fees from zero to about EUR 1,000. The headline fee is rarely the full cost: EUDAMED and UDI registrations, extra devices, mandate changes and exit letters are often billed separately. Since the AR is jointly liable with you, a suspiciously cheap one is usually one that does not check your file.
An Authorised Representative is not a mailing address. Under the MDR and IVDR it is a legally accountable party with its own tasks, inspections and liability.
The AR’s minimum tasks are set out in Art. 11(3) MDR/IVDR and explained in MDCG 2022-16:
The PRRC (Person Responsible for Regulatory Compliance) is a named, qualified person: a relevant degree plus one year of regulatory or QMS experience with devices, or four years of such experience (MDCG 2019-7). Micro and small manufacturers may use an external PRRC who is “permanently and continuously at their disposal”; larger manufacturers need one inside the organisation. Separately, the AR itself must have its own PRRC (Art. 15(6)), who cannot be the manufacturer’s PRRC.
| Usually included | Often billed separately |
|---|---|
| Mandate and acceptance letter | EUDAMED actor set-up (around EUR 300 where charged) |
| Verification of DoC and technical documentation | UDI/device registrations (up to about EUR 300 each) |
| Holding the documentation for authorities | Additional devices or device groups |
| Authority contact and requests | Mandate changes and release letters when you switch AR (about EUR 100–150) |
| Forwarding complaints and incidents | Certificates of Free Sale, translations, labelling or IFU drafting |
| The AR’s own name and address on your label | Writing or fixing the technical documentation itself |
Compare the total first-year cost for your actual portfolio — not the headline fee for one device.
Watch for line items presented as mandatory government fees. Under the MDR there is no EU-wide authority fee for appointing an AR; national registration fees, where they exist, are set by each country and should be shown with their legal source.
Since the MDR, the AR is jointly and severally liable with the manufacturer for defective devices (Art. 11(5)) — where the manufacturer has not met its Art. 10 obligations.
That changes the economics. A serious AR has to check your file, ask for proof of your liability cover (Art. 10(16)) and hold its own insurance. A very low fee usually means one of those steps is missing — and you find out during an authority request, an inspection or a recall.
The new EU Product Liability Directive (2024/2853), which member states must apply from 9 December 2026, also lists the manufacturer’s authorised representative among those an injured person can claim against when the manufacturer is outside the EU, and contract clauses cannot limit that liability towards the injured person. Expect AR contracts and insurance requirements to tighten accordingly.
Published 2026 rate cards range from about EUR 800 to 2,500 a year for a class I device and about EUR 1,500 to 5,500 for class III, plus set-up fees from zero to about EUR 1,000. Additional devices, EUDAMED and UDI registrations and mandate changes are often charged separately.
Yes, if you are a non-EU device or IVD manufacturer. You need a PRRC for your own organisation (micro and small enterprises may use an external one), and your AR must have its own, different PRRC.
PRRC-as-a-service prices are not published; they are quoted individually and depend on portfolio size, vigilance volume and how much release and documentation work is needed. The AR’s own PRRC should be included in the AR fee.
Yes. Under Art. 11(5) MDR/IVDR the AR is jointly and severally liable with the manufacturer for defective devices where the manufacturer has not met its obligations. The new Product Liability Directive, applicable from 9 December 2026, adds liability towards injured persons.
Legally it can, if it accepts the mandate and meets the requirements, but it creates a conflict of interest and ties your labelling and documentation to a commercial partner you may want to change.
The Pathway & Role Map names the regime and every legally required role for your product, with a realistic timeline — fixed price, five business days.