Do I Need an EU Authorized Representative?
Use the quick eligibility tool below, then review the criteria and responsibilities. If you need an EU Authorized Representative, Cruxi can match you with vetted providers.
Compare EU Authorized Representatives Estimate CostUnder EU MDR and IVDR, manufacturers established outside the EU/EEA must designate an EU Authorized Representative before placing medical devices or IVDs on the EU market. Selling without one is non-compliant and can lead to enforcement and market access issues. The AR must be a legal entity established in the EU/EEA and is responsible for specific regulatory tasks on your behalf. New to the term? See What is an EC rep?
Quick Eligibility Tool
Answer four questions for a directional view. This is not legal advice — use it to decide whether to consult an EU Authorized Representative.
Core Criteria (EU MDR + IVDR Article 11)
Non‑EU manufacturers must appoint an EU Authorized Representative before placing medical devices or IVDs on the EU/EEA market. EU‑established manufacturers do not need an Authorized Representative for EU market access.[1][2]
Not sure if you’re placing on the EU/EEA market?
Use this helper to check if your activity is considered “placing on the market.”
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This helper clarifies whether you are the legal manufacturer under MDR/IVDR.
What an EU Authorized Representative is responsible for
Under EU MDR Article 11 and IVDR Article 11, the Authorized Representative acts on behalf of the non‑EU manufacturer and has specific regulatory obligations. In practice these typically include:[1][2]
- Mandate: A written mandate must be in place between the manufacturer and the AR defining the scope of representation.
- Documentation: Verifying that the EU declaration of conformity and technical documentation have been drawn up and that the manufacturer has complied with registration and post-market obligations.
- EUDAMED: The AR must register in EUDAMED (European Database on Medical Devices) and obtain a Statutory Registration Number (SRN).
- Authorities: Cooperating with competent authorities, including providing documentation and information on request and forwarding requests from authorities to the manufacturer.
- Vigilance: Depending on the mandate, the AR may support or handle serious incident reporting and field safety corrective actions.
The AR must also have a PRRC (Person Responsible for Regulatory Compliance) meeting the Article 15 requirements. Many EU AR service providers offer both representation and PRRC support.
EU AR vs CH‑REP vs PRRC (Quick Comparison)
EU Authorized Representative (EU AR): A legal entity in the EU/EEA appointed by non‑EU manufacturers under MDR/IVDR Article 11.
Swiss Authorized Representative (CH‑REP): A legal entity in Switzerland appointed by non‑Swiss manufacturers under MedDO/IvDO.
PRRC: A qualified person responsible for regulatory compliance inside the manufacturer or AR organization (MDR/IVDR Article 15).
FAQ
Can an EU Authorized Representative also be an importer or distributor?
Not typically. The Authorized Representative is designated by the non‑EU manufacturer and has distinct responsibilities under MDR/IVDR.
Do EU manufacturers need an Authorized Representative?
No. EU‑established manufacturers do not need an EU Authorized Representative for EU market access.
Is the requirement the same for MDR and IVDR?
Yes. MDR and IVDR both require non‑EU manufacturers to appoint an EU Authorized Representative.
When do I need to appoint an EU AR?
You must have an EU Authorized Representative designated before you place devices or IVDs on the EU/EEA market. If you are already selling in the EU without one, you are non-compliant and should appoint an AR and put a mandate in place as soon as possible. The AR will need to register in EUDAMED and support your regulatory obligations.
What about the UK / Great Britain?
Great Britain (England, Scotland, Wales) has its own requirement for a UK Responsible Person for non-UK manufacturers under UK MDR 2002. Northern Ireland follows EU rules. If you sell in both the EU and GB, you typically need an EU AR for the EU/EEA and a UK Responsible Person for GB. Some providers offer both; confirm scope when requesting quotes.
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[1] EU MDR Article 11 — Authorized Representative requirements.
[2] EU IVDR Article 11 — Authorized Representative requirements.
This page is for informational purposes only and does not constitute legal advice. Cruxi is a marketplace/matching service; we are not a law firm and do not provide legal advice. See our Privacy Policy for how we share data with matched providers.