Authorized Representative EU
Authorized Representative work
Medical Device Regulations (MDR) Authorized Representative Resposabilities:
Authorized Representative (EC Rep): An authorized representative is a natural or legal person established within the European Union who receives and accepts a written mandate from a manufacturer located outside the EU to act on the manufacturer's behalf for specified tasks related to regulatory obligations under the Regulations.
Responsibilities outlined in the Regulations: The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) describe the obligations of authorized representatives, including verifying the EU declaration of conformity, reviewing technical documentation, and ensuring compliance with the appropriate conformity assessment procedures.
Delegation of tasks: The Regulations specify the tasks that can be delegated by the manufacturer to the authorized representative and the conditions under which delegation is permitted. A precise mandate should cover this relationship.
Document retention and accessibility: Authorized representatives are required to keep opies of all relevant documents, including technical documentation, declarations of conformity, and certificates, and make them accessible to authorities upon request.
EUDAMED registration: Authorized representatives must verify that the manufacturer has registered the necessary information in EUDAMED, the EU database for medical devices.
Cooperation and reporting: Authorized representatives are expected to cooperate with authorities on preventive and corrective actions, promptly inform the manufacturer about complaints and authorities' requests, and liaise with relevant bodies involved in the conformity assessment process.
Liability and termination: If the manufacturer fails to fulfill its obligations, both the authorized representative and the manufacturer may be held liable for defective devices. The authorized representative has the right to terminate the mandate in case of non-compliance.
Exclusive responsibilities of the manufacturer: Certain activities, such as device design, quality management system, and drafting of technical documentation, cannot be delegated to the authorized representative and remain the manufacturer's sole responsibility.
Access to regulatory compliance personnel: Authorized representatives should have continuous access to individuals responsible for regulatory compliance.
Changing authorized representatives: A proper agreement defining the arrangements between the manufacturer, outgoing authorized representative, and incoming authorized representative is required for a change in representation.
