A European Authorized EU Representative is defined as a natural or legal person within the European Union who has accepted a written mandate from a manufacturer, located outside the EU, to act on its behalf in relation to specific tasks under MDR or IVDR. Specifically, Authorized Representatives play a critical role in ensuring device compliance and serving as a point of contact for European authorities and notified bodies.
MDR and IVDR describe the tasks that the manufacturer can delegate to the Authorized Representative and the conditions under which this can be carried out. This relationship must be covered by a precise mandate agreed between the EC REP and the manufacturer. The Authorized Representative will carry out the tasks specified in the mandate. A copy of the mandate will be provided by the Authorized Representative to the competent authority, upon request.
The Authorized Representative is responsible for defective medical devices along with the manufacturer, as well as any default by the manufacturer.
Mandatory tasks of the Authorized Representative according to MDR and IVDR
MDR and IVDR clearly describe the core role of the Authorized Representative and their obligations, which should be mentioned in the mandate:
- Verify that the EU declaration of conformity and the technical documentation of the product have been drawn up and, where appropriate, that the manufacturer has followed the relevant conformity assessment procedure.
- Keep a copy of the technical documentation, the EU declaration of conformity and, where appropriate, a copy of the corresponding certificate, including its modifications and supplements, available to the competent authorities.
- Comply with FDA Registration obligations.
- In response to the request of a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product.
- Transmit to the manufacturer any request for samples or access to a product by a competent authority of the Member State in which the authorized representative has its registered office, and verify that said authority receives them or that access is granted.
- Cooperate with the competent authorities in any preventive or corrective action taken to eliminate or, if this is not possible, mitigate the risks posed by the products.
- Immediately notify the manufacturer of claims and reports from health professionals, patients or users about alleged incidents related to a product for which it has been designated.
