EU Authorised Representative (EU AR)
We support non‑EU manufacturers with a compliant EU Authorised Representative setup and ongoing regulatory communication.
When you need an EU Authorised Representative
If your company is established outside the European Union and you place certain products on the EU market, EU product legislation may require you to appoint an EU Authorised Representative and define a written mandate.
Typical cases include medical devices (MDR) and in vitro diagnostic devices (IVDR), but similar representation / “authorised person” concepts also appear in other product compliance regimes.
What we do as your EU AR
- Contracting: written mandate + role scoping (what is AR vs. manufacturer vs. importer responsibilities)
- Document readiness check (technical documentation structure, declarations, key registrations)
- Regulatory communication channel with EU authorities (where applicable)
- Support with post‑market obligations and requests for information (process setup)
- Clear onboarding checklist and handover package
How to start
- Send product category + target EU countries
- We confirm the applicable regulation and the right representation model
- We prepare mandate wording and onboarding checklist
Contact us
Note: This website provides general information. Specific obligations depend on your product and applicable EU legislation.
