Understanding the Role of EC Representatives and EAR
Responsibilities and Obligations of Authorized Representatives for Medical Device Manufacturers in the European Union
An EC Representative, also known as an authorized representative, refers to any individual or organization located within the European Union (EU) that has been granted a written mandate by a manufacturer outside the EU. The EC Representative acts on behalf of the manufacturer and fulfills specific obligations outlined in the Regulations.
The responsibilities of an authorized representative are defined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), particularly in Article 11. For further guidance, the 'Blue Guide' on the implementation of EU product rules can provide additional information.
The Regulations specify the tasks that can be delegated by the manufacturer to the authorized representative, along with the conditions that must be met for such delegation to occur. The relationship between the manufacturer and the authorized representative should be documented in a precise mandate.
At the minimum, authorized representatives are required to verify that the manufacturer has prepared the EU declaration of conformity, technical documentation, and, if applicable, has completed an appropriate conformity assessment procedure (MDR/IVDR Article 11(3)(a)).
Additionally, authorized representatives must maintain copies of all relevant documents and make them accessible to authorities upon request. This includes technical documentation, declarations of conformity, and certificates, including any amendments or supplements (MDR/IVDR Article 11(3)(b)).
Furthermore, authorized representatives are responsible for verifying that the manufacturer has registered the necessary information in EUDAMED, the EU database on medical devices (MDR/IVDR Article 11(3)(c)).
Authorized representatives are expected to cooperate with authorities regarding preventive and corrective actions, promptly inform the manufacturer about complaints, and provide authorities with requested device samples.
If the manufacturer, located outside the EU, fails to fulfill its obligations under the Regulations, both the manufacturer and the authorized representative may be held liable for defective devices (MDR/IVDR Article 11(5)).
In case the manufacturer acts contrary to its obligations, the authorized representative should terminate the mandate. The authorized representative is obliged to immediately inform the Member State where it is established and, if applicable, the Notified Body involved in the conformity assessment, providing reasons for the termination (MDR/IVDR Article 11(3)(h)).
Certain activities cannot be delegated to an authorized representative and are exclusive responsibilities of the manufacturer. These include requirements related to device design, quality management system, and drafting of technical documentation (MDR/IVDR Article 11(4)).
It is essential for the authorized representative to have permanent and continuous access to an individual responsible for regulatory compliance (MDR/IVDR Article 15(6)).
A change of authorized representative requires a formal agreement that outlines the arrangements between the manufacturer and both the outgoing and incoming authorized representatives (MDR/IVDR Article 12).