Manufacturers who are not based in the EU must have an authorised representative. The EU has published its first guidance, MDCG 2022-16, a 10-page document, clarifying the role of the authorised representatives, an important function in the context of Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR).
The authorised representatives’ minimum tasks are listed in article 11(3) of the MDR and IVDR.
The manufacturer and the authorised representative must set up their written mandate which in turn shall reflect the minimum requirements of the MDR and IVDR, article 11(3), regardless of whether the authorised representative is independent/outside of, or is part of, the same larger organisation as the manufacturer. However, the mandate may include additional responsibilities agreed between the two participants.
Furthermore, authorised representatives are obliged to comply to registration requirements and to verify that the manufacturer has fulfilled its registration requirements.
Regarding liability, if the manufacturer is not established in a member state and has not fulfilled the requirements in article 10, the authorised representative is legally responsible for faulty devices on the same basis as, and jointly and severally with, the manufacturer. This is despite the manufacturer not being able to delegate its obligations under the MDR and IVDR. So, it is in the authorised representative interest to confirm that the manufacture has satisfied its obligations, including the requirement to have measures in position to have adequate financial coverage, such as liability coverage, under article 10(16) of the Regulations.
Finally, the mandate should allow the authorised representative to end the mandate if the manufacturer acts in opposition to its obligations under the MDR and IVDR.
Additional topics are considered in the guidance, such as legacy devices, a change of the authorised representative and the Person responsible for Regulatory Compliance.
Should you have any questions or concerns, please don’t hesitate to get in touch with mdi Europa.
Source: MDCG, Medtech Insight (an Informa product)