EU AR Mandate Readiness Checklist

Before you appoint an EU Authorized Representative (EC rep), use this checklist to see if you have the basics in place. Not legal advice—use it to prepare and then compare vetted EU AR providers.

Compare EU AR Providers & Get Quotes Do I Need an EU AR? Cost Calculator

Are you ready to appoint an EU Authorized Representative?

Tick each item that applies. The AR will need to verify that you have these in order; having them ready speeds up the mandate.

We have (or will have) an EU Declaration of Conformity for the device(s). The AR must verify the DoC has been properly drawn up (MDR/IVDR Article 11).

Technical documentation is available and can be made accessible to the AR and authorities on request. The AR keeps copies and must be able to provide them to competent authorities.

Appropriate conformity assessment has been (or will be) carried out for the device(s). The AR verifies that the correct procedure was followed (e.g. self-assessment for Class I, notified body for higher classes).

We understand we (and our AR) must be registered in EUDAMED and that the AR will support registration. Non-EU manufacturers register in EUDAMED; the AR is involved in the process and must be registered.

We have (or will designate) a person responsible for regulatory compliance (PRRC) as required by MDR/IVDR Article 15. The AR must have permanent access to a PRRC; you must have one too as manufacturer.

We are prepared to sign a written mandate defining the AR’s tasks and responsibilities. The mandate must be in writing and specify the tasks (Article 11).

What the EU AR will need from you

Typical items: written mandate, copy of DoC, access to technical documentation, device/UDI information for EUDAMED, contact for PRRC, and payment/contract terms. Requirements vary by provider—compare scope when you request quotes.

This checklist is for planning only and does not constitute legal advice. Final requirements are set by your chosen EU AR and by MDR/IVDR. See our Privacy Policy.