For manufacturers who are not established in the European Union, the authorized representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Medical Devices Regulation (MDR) and in vitro diagnostic medical devices (IVDR) outlines the obligations and introduces enhanced responsibility for the authorized representative.
Designation and mandate
A device may only be placed on the Union market if the manufacturer designates a sole authorized representative. A manufacturer can have more than one authorized representative if the devices fall under different generic device groups (i.e. for one specific generic device group, the manufacturer should designate only one ‘sole’ authorized representative’).
“The manufacturer and authorized representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed upon by the parties.” “Whether the authorized representative is independent/outside of or part of the same larger organization as the manufacturer”, is according to the guidance.
Article 11(3) requires the authorized representative to carry out the tasks outlined in their manufacturer mandate. The authorized representative must provide a copy of the mandate to the competent authority upon request. The article also specifies minimum tasks that the mandate should cover, but the authorized representative may agree to take on additional responsibilities. Certain responsibilities cannot be delegated to authorized representatives by manufacturers.
Registration & verification obligations
a) The authorized representatives’ own obligations: The authorized representative for economic operators in EUDAMED is required to register his or her details with the European Data Protection Agency (EUDAMED) and comply with the registration obligations.
b) The authorized representative’s verification obligations toward the manufacturer: A manufacturer’s obligation is to register its information and devices in EUDAMED cannot be delegated to the authorized representative. The authorized representative has the obligation to verify that the manufacturer has complied with its UDI and devices registration obligations.
Minimum tasks & responsibilities of the authorised representative
The manufacturer should enable the authorized representative to perform the tasks mandated by the Regulations. The authorized representative verifies that the EU declaration of conformity and technical documentation have been drawn up (i.e. checks the existence of such documents) and that an appropriate conformity assessment procedure has been carried out by the manufacturer.
Liability
The authorized representative is legally liable for defective devices under the following terms: “Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10.
Termination of the mandate
The mandate is ‘effective at least for all devices of the same generic device group’ of a manufacturer, unless a specific device is removed/withdrawn from the market. In the event of a problematic termination, the out-going authorized representative is advised to, inform the competent authorities and where applicable, the notified body.
Change of authorized representative
An agreement between the manufacturer and their authorized representative and the incoming authorized representative must be in place for each mandate termination. The Regulations specify the minimum aspects of such an agreement including relevant dates, transfer of documentation and communication.
Person Responsible for Regulatory Compliance (PRRC)
Authorized representatives of ‘in vitro diagnostic medical devices’ (IVDRs) in the EU should have permanently and continuously at their disposal at least one Person Responsible for Regulatory Compliance (PRRC). Authorized representatives whose mandate includes ‘legacy devices’ are not required to appoint a PRRC for those devices.
Market Surveillance
Authorized representatives may be consulted in the context of market surveillance measures taken regarding non-compliance and required to make documentation and information available to competent authorities and subjected to announced audits as part of market surveillance.
Transitional provisions
The requirements for authorized representatives under the Directives continue to apply for ‘legacy devices’. The mandate between the manufacturer and the authorized representative should be updated accordingly. The market surveillance cooperation provisions also apply to authorized representatives whose mandate with the manufacturer covers ‘legacy devices’.
For a market entry that is compliant, it is recommended to consult with a regulatory expert. Keep yourself updated and ensure compliance with regulations.
