Compare EU Authorized Representative Providers (2025)

Not all EU Authorized Representative providers are the same. Pricing structures, geographic coverage, PRRC availability and contractual liability vary substantially across the market. Use the filters and table below to narrow down providers that match your specific situation, then request formal quotes from shortlisted candidates.

* Prices are indicative market ranges as of 2025. Actual quotes depend on portfolio size, device risk class and contract duration. Always request a formal quote before committing.

What to look for when comparing EC REP providers

Three dimensions determine which EC REP is the right fit for your situation — and getting these wrong costs significantly more than a slightly higher annual fee.

What is an EU Authorized Representative (EC REP)?

An EU Authorized Representative (EC REP) is a legal entity established in the EU that a non-EU medical device manufacturer designates to act on their behalf under MDR 2017/745 and IVDR 2017/746. The EC REP's name and address must appear on the device label, and they serve as the primary contact point for EU market surveillance authorities. The EC REP holds copies of technical documentation and the Declaration of Conformity, and is registered in EUDAMED with a Single Registration Number (SRN).

Flat fee vs per-device: which model is cheaper for small manufacturers?

For manufacturers with one to three products, per-device pricing — typically €300–800 per SKU per year — is almost always cheaper than flat fee arrangements. Flat fee models start at around €600–800 per year for entry-level packages but rarely cover large portfolios at that price point. The crossover point where flat fee becomes more economical is typically around four to six devices, depending on the provider's tier structure. Request itemised quotes from at least two providers before committing to a pricing model.

Do I need a PRRC as part of my EC REP service?

Under MDR Article 15, manufacturers and their EU Authorized Representatives must have at least one PRRC (Person Responsible for Regulatory Compliance) on staff or under contract. If you lack an in-house PRRC — which is common for small non-EU manufacturers — you must either contract the service separately or choose an EC REP that includes it. Some providers bundle PRRC coverage in their standard mandate; others charge it as an add-on at €200–800 per year extra. Always confirm this point explicitly before signing.

Can one EC REP cover EU, UK and Switzerland?

No single entity can legally serve as EC REP, UK Responsible Person (UKRP) and Swiss Authorized Representative (CH REP) simultaneously — each jurisdiction requires a separately established legal entity. However, some EC REP groups operate affiliated entities across all three markets and offer bundled three-territory mandates under a single commercial relationship. EMERGO by UL and Intertek are examples of this multi-jurisdiction model. If you only need EU coverage, there is no reason to pay for bundled multi-territory packages.

How long does it take to appoint an EC REP?

Once you select a provider and sign the mandate agreement, appointment typically takes 5–15 business days. The provider needs to register in EUDAMED (if not already) and issue a confirmation letter with their SRN that you can reference in your technical documentation. Some providers offer accelerated onboarding for an additional fee. Note that the EC REP appointment must be in place before you legally place devices on the EU market — do not treat this as a post-launch formality.

What liability does an EC REP carry?

Under MDR Article 11(3), EC REPs can be held jointly and severally liable for defective devices alongside the manufacturer. This is not nominal liability — authorities can pursue the EC REP directly when the non-EU manufacturer is unreachable. Reputable EC REP providers carry professional indemnity insurance and product liability coverage; always request proof of insurance and verify limits before signing a mandate. Providers that offer unusually low fees without evidence of insurance coverage represent a significant compliance and financial risk.