EU Authorized Representative List: Official Source vs Directory
The official source is EUDAMED—a searchable database where ARs register. There is no simple downloadable list. Compare verified EU AR providers from Cruxi's vetted directory. What does EC rep mean?
Official Source: EUDAMED Actor Registration
EUDAMED (European Database on Medical Devices) is the official EU system established under MDR/IVDR. The Actor registration module allows you to search for economic operators, including authorized representatives, who have registered with a Statutory Registration Number (SRN). It is a searchable database—not a simple downloadable list. Access requires EU Login.
There is no separate "official EU AR list" document. EUDAMED is the single official source.
What the EU Authorized Representative Role Entails
The EU AR is a legal entity established in the EU/EEA that the non-EU manufacturer appoints by written mandate. Under MDR/IVDR Article 11, the AR verifies that the manufacturer has drawn up the EU declaration of conformity and technical documentation, that the manufacturer has complied with registration and post-market obligations, and the AR cooperates with competent authorities (e.g. providing documentation, forwarding requests). The AR must register in EUDAMED and obtain an SRN (Statutory Registration Number). The AR must also have a PRRC (Person Responsible for Regulatory Compliance) meeting Article 15 requirements. Many EU AR service providers offer representation plus vigilance support and compliance assistance.
How to Compare EU AR Providers
Because there is no single "official list" to choose from, you compare service providers by:
- Establishment and SRN: The AR must be established in the EU/EEA and registered in EUDAMED with an SRN. Confirm they have an active SRN.
- Coverage: MDR only, IVDR only, or both—match to your device types.
- Scope: Basic representation vs AR + vigilance support vs AR + full compliance support (e.g. PMS, documentation review).
- Mandate and contract: Clear written mandate, confidentiality, liability, term, and termination.
- Response and languages: Response SLAs and language support for authorities and your team.
Request quotes from several providers and compare coverage, experience, and pricing. Cruxi's directory helps you discover and compare vetted EU AR providers in one place.
EUDAMED vs Cruxi Directory
EUDAMED shows which ARs have registered—it does not help you compare services, pricing, or capabilities. Cruxi's directory is a curated list of EU Authorized Representative service providers where you can compare and request quotes. It is not an official list—it is a commercial directory for procurement.
Cruxi Vetted EU Authorized Representative Providers
Cruxi maintains a directory of verified EU AR service providers. These providers have been vetted for EU establishment, MDR/IVDR experience, and mandate handling. Important: These providers are not "official" or "approved" by the EU—they are verified service providers. Always do your own due diligence.
FAQ
Is there an official EU Authorized Representative list?
There is no single downloadable "official EU AR list." The official source is EUDAMED's Actor registration module, where ARs register and obtain an SRN. It is a searchable database, not a simple list. Cruxi's directory is a curated list of service providers for comparison and quotes.
How can I verify an AR is registered in EUDAMED?
You can search the EUDAMED Actor registration module (with EU Login) for the AR's name or SRN. Ask the provider for their SRN and confirm it appears in EUDAMED. Registration is mandatory under MDR/IVDR.
Can one EU AR represent multiple manufacturers?
Yes. An EU Authorized Representative can act for multiple non-EU manufacturers under separate mandates. Each manufacturer has its own written mandate and the AR fulfils the Article 11 obligations for each. Many EU AR service providers have many manufacturer clients.
Where can I compare EU AR service providers and get quotes?
Cruxi maintains a directory of verified EU Authorized Representative service providers. You can compare providers and request quotes—this is not an official list but a curated directory for comparison and procurement.
Sources & scope
EU Regulation 2017/745 (MDR) Article 11 and EU Regulation 2017/746 (IVDR) Article 11 — Authorized Representative. EUDAMED is operated by the European Commission. This page is for information only and does not constitute legal advice.
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