The Medical Devices Coordination Group (MDCG) has issued new guidance on authorised representatives for the EU Medical Devices Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR). The guidance addresses the designation, termination, and obligations of authorised representatives.
This will be of particular importance to individuals or companies already designated as authorised representatives. Non-EU manufacturers of medical devices who are seeking to sell their products on the EU market should also take note. For these manufacturers, authorised representatives play a pivotal role in complying with the MDR or IVDR, as applicable.
Requirement to designate an Authorised Representative
Article 11(1) of the EU MDR/IVDR establishes the requirement to designate an authorised representative. This generally applies to manufacturers of devices[1] that are not established in an EU Member State. In such cases, the authorised representative acts on the manufacturers behalf in relation to specific obligations under the EU regulations.
However, there are certain circumstances where the requirement does not apply. In particular, this is not necessary for manufacturers of devices that are intended for clinical investigation (under the MDR) or devices for performance study (under the IVDR). Instead, in these cases, the sponsor of the study must appoint an EU-based natural or legal person to act as their legal representative.
It is important to note that different rules may apply to non-EU based manufacturers depending on their portfolio of medical devices. For instance, if a manufacturer only produces medical devices which have the same or similar intended purposes, or commonality of technology (i.e. belong to the same "generic device group"), they should designate only one authorised representative. By contrast, if devices fall under different generic groups or do not fall into a generic device group at all, the manufacturer may need to designate more than one authorised representative.
Role of an authorised representative
The MDR and IVDR prescribe a set of minimum tasks that the authorised representative should perform.
For example, an authorised representative must keep available a copy of the manufacturer’s technical documentation. However, the regulations only prescribe the minimum requirements for the authorised representative’s tasks - the manufacturer and the representative may agree on a wider mandate for this role. For instance, the guidance specifies that the manufacturer may require that the representative lodge an application for conformity assessment with a notified body on their behalf.
However, the manufacturer cannot assign the authorised representative any of their own obligations under Article 10 (1-4)(6)(7)(9-12) MDR, or Article 10 (1-6)(8)(9-11) IVDR. Nevertheless, the representative may assist in the performance of these tasks. The guidance additionally discusses in further detail the obligations of the authorised representative, as well as the extent and conditions for their liability.
The MDCG’s latest guidance document provides crucial clarity on the role of the authorised representative, and will ensure that manufacturers of medical devices who are based outside the EU who wish to sell their product on the Union market have a clearer understanding of both their obligations and the obligations of their authorised representative under the EU’s medical devices regulations.
We will be keeping an eye out for future MDCG publications. Subscribe to our newsletter to keep up to date on the most recent developments.
[1] The MDCG notes that the term device in this context includes: