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EU Authorized Representative Mandate

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What is an AR Mandate, and what should it include? #

The AR mandate is a legal agreement between the manufacturer and the EU Authorized Representative which should, as a minimum, include the obligations described below.

The obligations of the EU AR are laid down in Article 11 of both Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR). These obligations include:

  1. Verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
  2. Keeping available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56 [IVDR 51], at the disposal of competent authorities for the period referred to in Article 10(8) [IVDR 10(7)];
  3. Complying with the registration obligations laid down in Article 31 [IVDR 28] and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29 [IVDR 26];
  4. In response to a request from a competent authority, providing that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
  5. Forwarding to the manufacturer any request by a competent authority of the Member State in which the authorized representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
  6. Cooperating with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
  7. Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
  8. Terminating the mandate if the manufacturer acts contrary to its obligations under the Regulations.

It would typically also include the terms of payment, termination, the period of cover, and the devices covered by the AR. Some AR mandates are also valid for a particular period and would thus be considered to have an expiration date. The manufacturer’s obligations may also be listed in the mandate.

The mandate may include additional terms, as agreed upon by both parties, however, in no circumstance is it allowed to delegate the manufacturer’s obligations laid down in:

  • EU MDR Article 10 paragraphs 1-4,6-7,9-12.
  • EU IVDR Article 10 paragraphs 1-6, 8-12.

It is critical that the mandate makes clear reference to the devices the AR is being designated to represent; a list which may be amended from time to time.

If at any point, the AR becomes aware that the manufacturer is acting contrary to its obligations under the Regulations, they have an obligation to terminate the mandate. However, this would typically follow a warning made by the AR and a chance for the manufacturer to correct any deficiencies. In the event that the mandate is terminated on such grounds, the AR should inform the Competent Authority in the Member State in which they are based, as well as, if applicable, the relevant Notified Body who has issued that certificate.