7 February 2023
Due to the changes introduced by the European regulation, it is necessary to have a good understanding of the role and responsibilities of the figure of the European Authorised Representative whose requirements are stated in Art. 11 and 12 of MDR (EU) 2017/745 in addition to being present throughout the whole text. This Economic Operator, in fact, for non-EU Manufacturers covers functions of fundamental importance in the process of CE marking of Medical Devices and conformity of devices to be marketed on the European territory.
A European Authorised Representative is defined as any natural or legal person established in the European Union who has received, and accepted, from the Manufacturer established outside the Union, a written mandate authorising him to act on behalf of the Manufacturer in relation to certain activities in connection with the latter’s obligations under MDR (EU) 2017/745.
The Directives 93/42/EEC and 2007/47/EC already regulated the figure of the European Authorised Representative, specifying the need for the Manufacturer to designate this figure; however, after the issuing of the “Guideline for Authorised Representatives – MEDDEV 2.5/10”, the duties and responsibilities of the Manufacturer and the Authorised Representative began to be delineated, specifying that it is the former who is responsible for the obligations relating to the placing of devices on the market in accordance with the Directive.
This scenario is completely overturned with the European Regulation 2017/745. In fact, the obligations and requirements of the Authorised Representative are clearly spelled out in Article 11 of MDR (UE) 2017/745, which outlines a more proactive and substantial product control role than in the past. In particular, the European Authorised Representative has the task of verifying that the devices placed on the market comply with the conformity requirements of the new regulatory text, of interfacing with the Competent Authorities in Europe and with the non-EU Manufacturer and of interacting with Importers and Distributors of devices especially with regard to vigilance and surveillance activities, but he also has direct responsibility in case of damage caused by a defective product.
This means that, in the event of problems arising from a lack of safety or effectiveness of the devices that caused possible physical injury to the patient, the Operator or third party, both the non-EU Manufacturer and the Authorised Representative are directly sued for legal liability.
This is clearly stated in Article 11(5), which stipulates that the Authorised Representative is jointly and severally liable before the law for defective devices on the same basis as the Manufacturer.
The Manufacturer and the European Authorised Representative must sign a specific written mandate clearly setting out their duties. The duties of the Authorised Representative include:
- Ensure that the EU Declaration of Conformity (DOC) and the Technical Documentation are always drawn up (MRD/IVDR Article 11.3.a) and keep a copy available to the Competent Authority at all times (MDR/IVDR Article 11.3.b);
- Comply with the registration requirements for Economic Operators in the EUDAMED database (MDR/IVDR Art. 11.3.c);
- Verify that the Manufacturer has correctly assigned a UDI code to the device: in addition, the name of the Authorised Representative and the address of its registered office must be indicated on the label and on the instructions for use of the device (Annex I, points 23.2 and 23.4);
- Manage contacts with the Competent Authorities and, at their request, provide all the information and documentation necessary to prove that the device complies with legal requirements;
- Collaborate with the Competent Authorities in case of corrective or preventive actions to eliminate or reduce the risks of the devices;
- Forward Competent Authorities’ requests to the Manufacturer and inform him in case of reports, problems, complaints or feedback from Healthcare Professionals and users;
- Terminate the mandate if the Manufacturer acts contrary to the obligations under MDR and inform the Competent Authority in case of termination of the mandate (MDR/IVDR Article 11.3.h);
- Have a Person Responsible for Regulatory Compliance (PRRC) permanently and continuously available (MDR/IVDR Article 15.6).
The regulation also describes the activities which cannot be delegated to an Authorised Representative and which cannot form part of the mandate between a Manufacturer and an Authorised Representative (MDR Article 11(4)): for example, provisions relating to the design of a device, the quality management system or the drafting of technical documents are the exclusive responsibility of the Manufacturer.
Finally, if one intends to change one’s European Authorised Representative, an appropriate agreement must be concluded defining the arrangements between the Manufacturer and the outgoing and the incoming Authorised Representative (MDR/IVDR Art. 12).
As an Economic Operator, the European Authorised Representative may be subject to inspections by the Notified Body appointed by the Manufacturer and by the Competent Authorities, which may carry out checks at any time to verify and determine that the Authorised Representative has understood his role, has direct access to the Technical Documentation and has implemented the quality system processes.
The choice of the European Authorised Representative, therefore, must be very careful, as appointing a European Importer or Distributor for this role, or an organisation that does not have the necessary processes in place to meet the minimum regulatory requirements necessary to comply with the legislation, is a high risk for the Manufacturer in the marketing of its devices.
On the other hand, accepting the responsibility of taking on the role of European Authorised Representative is a choice to be considered by organisations that cannot support or cope with the requirements of the legislation.
As the European Authorised Representative, Thema is able to guarantee full compliance with MDR and ensure compliance with assigned obligations through an organisation managed by ISO 13485:2016 compliant processes, adequate Manufacturer and product controls and pre-screening activities of all documentation, as well as adequate insurance coverage to ensure that the device is marketed in accordance with mandatory regulatory requirements.
>>> Through our strategic-regulatory consulting services, CE certification support, Thema can support you in fulfilling the requirements of the Medical Device Regulation MDR (EU) 2017/745 and In Vitro Diagnostic Devices IVDR (EU) 2017/746.
Contact us for more information.