Authorised representative overview

AF Pharma understands the critical role of the European Authorized Representative (also known as EU Auth. Rep., EC Rep, or AR) in the CE Marking process for medical devices, as mandated by the current legislation. Without an Authorized Representative, it is simply not possible to sell your products within the European Union. We offer our services to assist you in comprehending and fulfilling the corresponding obligations.

As per the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the EU Authorized Representative assumes a specific and well-defined role along with its associated obligations. This role includes, among other responsibilities, acting on behalf of manufacturers to communicate with competent authorities.

The definition states that an "authorized representative" refers to a natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the Union. This mandate empowers the authorized representative to act on the manufacturer's behalf regarding specified tasks and obligations.

Guidance from the European Union on Authorized Representatives

Manufacturers who are not based in the EU must engage an authorized representative. The EU has published its first guidance, MDCG 2022-16, a 10-page document that clarifies the role of authorized representatives. This function is essential within the context of the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (MDR and IVDR).

The minimum tasks of authorized representatives are outlined in Article 11(3) of the MDR and IVDR.

Both the manufacturer and the authorized representative must establish a written mandate that reflects the minimum requirements specified in Article 11(3) of the MDR and IVDR. This applies regardless of whether the authorized representative is an independent entity or part of the same larger organization as the manufacturer. The mandate may also include additional responsibilities agreed upon between both parties.

Additionally, authorized representatives are obligated to comply with registration requirements and verify that the manufacturer has fulfilled its own registration requirements. Legally, the authorized representative shares responsibility for faulty devices with the manufacturer on the same basis and jointly and severally. This remains true even if the manufacturer is not established in a member state and has not met the requirements outlined in Article 10. Therefore, it is in the authorized representative's interest to ensure that the manufacturer has fulfilled its obligations, including the requirement to have adequate financial coverage, such as liability coverage, as stipulated in Article 10(16) of the Regulations.

Lastly, the mandate should grant the authorized representative the ability to terminate the agreement if the manufacturer acts contrary to its obligations under the MDR and IVDR.

The guidance document also covers additional topics such as legacy devices, changing authorized representatives, and the Person Responsible for Regulatory Compliance.

If you have any questions or concerns, please do not hesitate to contact AF Pharma. We are here to assist you.