For manufacturers who are not established in a Member State, their device may only be placed in the Union market, if the manufacturer designates a sole authorized representative (AR). Article 11 of the MDR and the IVDR outlines the obligations of (and introduces enhanced responsibility for) the AR.

This guidance is written for AR, manufacturers and other economic operators and provides clarification on the relevant requirements under the Regulations.

  1. 1. AR Designation and Mandate

A manufacturer can have more than one AR if the devices fall under different generic device groups. However, for one specific device group, the manufacturer should designate only one AR (sole AR).

The manufacturer and the AR are free to configure the structure of their contractual relationship as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations.

Importers should verify that the AR in accordance with Article 11 has been designated by the manufacturer through checking that the AR’s name appears on relevant documentation and is using the EUDAMED database.

  1. 2. Registration & Verification Obligations

The AR must register its details in EUDAMED according to Article 31 of the MDR. In addition to registration, the AR must verify that:

◆   its own registered information is updated within one week of any change occurring.

◆   the accuracy of the date it has submitted

  The AR’s verification obligations toward the manufacturer

  1. 3. Minimum Tasks & Responsibilities of the AR

The minimum tasks & responsibilities of the AR are described in Article 11(3) of the Regulations. The manufacturer should enable the AR to perform the tasks mandated.

To ensure the AR can comply with the requirements and cooperate with the authorities effectively, the AR is advised to maintain open communication lines with the manufacturer.

The AR should be able to demonstrate to the competent authority that the verifications of requirements have been performed through their internal records.

In addition to cooperation with the competent authorities upon request in vigilance or market surveillance cases, meeting this requirement may involve the AR coordinating and communicating with importers and distributors and other entities in the supply chain.

  1. 4. Liability

Whilst the manufacturer cannot delegate its obligations referred to in Article 11(4), the AR may nonetheless remain legally liable for defective devices if the manufacturer has not complied with its obligations laid down in Article 10 of the Regulations.

The AR’s potential joint liability is conditional upon the manufacturer’s failure to comply with its obligations, and the AR can therefore only be liable in cases where:

◆   The manufacturer’s liability for a defective device is established under the applicable union or national law; and

◆   It is established that the manufacturer has not complied with its obligations under Article 10 MDR/IVDR.

In line with the above, the AR should verify that the manufacturer has fulfilled its obligations, including the manufacturer’s obligation to have measures in place to provide sufficient financial coverage.

Matters of liability would ultimately be decided by the competent courts. This includes whether a causal relationship needs to be established between the manufacturers’ non-compliance with its obligations under Article 10 of the Regulations and the damage caused by a defective device, in order to trigger the AR’s joint and several liability.

  1. 5. Termination of the Mandate
    1. The mandate should enable the AR to terminate the mandate if the manufacturer acts contrary to its obligations under the Regulations. The termination of the mandate is only possible with respect to the whole generic device group and not a specific device within that group, unless the specific device is removed from the market and so is outside the scope of the effective mandate.
    2. In the event of a problematic termination, the AR is also advised to inform the competent authorities and the notified body.
  2. 6. Change of AR
    1. A tripartite agreement should exist under Article 12 of the Regulations, including: the date of termination of the mandate of the outgoing AR and date of beginning of the mandate of the incoming AR, the transfer of documents, the obligation of the outgoing AR after the end of the mandate etc.
  1. 7. Person Responsible for Regulatory Compliance (PRRC)
    1. Article 15(6) of the Regulations state that the AR shall have permanently and continuously at least one Person Responsible for Regulatory Compliance (PRRC), who possesses the requisite expertise regarding the regulatory requirements.
    2. Further guidance on the PRRC is included in the MDCG 2019-7. There should be a clear contractual relationship in place between the AR and the PRRC.
  2. 8. Market Surveillance
    1. In addition to the AR’s minimum responsibilities and other obligations covered in the mandate, it is noted that the AR:
      1. ◆   may be consulted in the context of market surveillance measures taken by competent authorities regarding devices presenting serious risks to health and safety of patients.
      2. ◆   may be required to make documentation and information available to the competent authorities as part of their market surveillance activities.
      3. ◆   may be subjected to announced and unannounced inspections by the competent authorities as part of their market surveillance activities.

Attachment: MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746