Roles and Responsibilities of
What is an EU Authorised Representative?
The Regulations describe the responsibilities of Authorised Representatives. Many of the general obligations of Authorised Representatives are described in MDR/IVDR Article 11.
An Authorised Representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations.
The Regulations also describe the tasks that can be delegated by the manufacturer to the Authorised Representative, and the conditions under which this can take place. This relationship should be covered by a precise mandate.
Authorised Representatives Obligations
At a minimum, Authorised Representatives obligations include verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer (MRD/IVDR Article 11(3)(a)). An Authorised Representative must also keep copies available of all documents and make them accessible to authorities on request. This includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements (MDR/IVDR Article 11(3)(b)).
In addition, Authorised Representatives will have to verify that the manufacturer has registered the requested information in EUDAMED (MDR/IVDR Article 11(3)(c)).
An Authorised Representative will have to cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
The Authorised Representative will be liable for defective devices together with the manufacturer, if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU (MDR/IVDR Article 11(5)).
The Authorised Representative should terminate the mandate if the manufacturer acts contrary to its obligations (MDR/IVDR Article 11(3)(h)). In such situations, the Authorised Representative shall immediately inform the Member State in which it is established and, where applicable, the Notified Body involved in the conformity assessment of the device, of the termination and the reasons behind it.
The Regulations also describe activities that cannot be delegated to an Authorised Representative, and that may not be part of the mandate between a manufacturer and an Authorised Representative (MDR/IVDR Article 11(4)). Examples include requirements related to the design of a device, the quality management system, or the drafting of technical documentation; these are the exclusive responsibilities of the manufacturer.
The Authorised Representative should have permanent and continuous access to a person responsible for regulatory compliance (MDR/IVDR Article 15(6)).
Authorised Representative Change
A change of an Authorised Representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new Authorised Representative (MDR/IVDR Article 12).