MDR Article 11 – Authorised Representative

MDR Article 11 Authorised Representative

All “non-EU” medical device manufacturers should have an authorised representative, if they want to sell their products within EU countries. This representative plays a role as a bridge between the authorities and the manufacturer according to MDR Article 11 Authorised Representative.

Manufacturer and AR should are required to come together and sign an agreement (mandate) explaining their tasks. All the tasks need to be clarified and all the informations should be provided in case of any representative change in this agreement. AR should perform the tasks of this agreement and comply with the registration obligations  (EUDAMED).

For the full regulation click here.

What are the duties of AR?

  1. Verify that the EU Declaration of Conformity (DOC) and technical documentations are always drew up.
  2. Keep available a copy of the technical documentation and the EU declaration of conformity.
  3. Comply with the registration obligations (EUDAMED).
  4. Prove that the device complies with legal requirements when requested by the competent authority
  5. Forward the requests of the competent authority to the manufacturer.
  6. Follow-up of corrective or preventive actions to be eliminated or mitigate the risks by cooperating with competent authorities.
  7. Inform the manufacturer if any problem occurs (complaints) or feedback is reported by the healthcare professionals, users
  8. Terminate the agreement (mandate) if the manufacturer acts contrary to its obligations under MDR.
  9. Inform the competent authority if it terminates the agreement.
  10. “IMPORTANT” Legally liable for the manufacturer, if non-eu manufacturer does not comply with the obligations.

Do you know how to prepare the content of the Technical File according to new MDR? Click here to get Technical File structure.

How to register in EUDAMED as a Non-EU manufacturer and get Single Registration Number (SRN)?

Manufacturer submits its actor registration request to the Authorised Representative. But first things first, AR should be registered in EUDAMED as an economic operator before your registration. After you check that your AR is registered, AR need to verify this request before transmitting this request to the authority in this phase. If everything all right, AR forwards your actor registration request to the authority via database.

The competent authority has three decisions upon this request. 

  • Corrections requested
  • Acceptation
  • Refusal


Find the EUDAMED Mandate Summary sample document at this link.

You can follow these instructions in the video below while you submit your request

What to do in case of changing your AR?

If you want to change your AR, you should sign a new agreement with the incoming AR and you should indicate following aspects in it:

  • Your termination date with your old AR
  • Beginning date of your new AR.
  • The date until which the outgoing authorised representative may be indicated in the label, or the outer packaging, or instructions for use, or catalogs and leaflets.
  • Transfer of technical documentations
  • If your old representative receives any feedback (complaint) about the products after he left, these complaints must be reported to the manufacturer or your new representative. Therefore, agreement should indicate this statement.B

Do you know what are the Vigilance Requirements of MDR? Click here to learn how to prepare the needed documents such as reporting of serious incidents. 

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