EU Authorized Representative

Foreign manufacturers must appoint an Authorized Representative for their products in the EC under European Commission Regulation 2017/745 on Medical Devices, Regulation (EU) No 2017/746 on in vitro diagnostic medical devices.
For each cosmetic product, there is a responsible person established in the Community under Regulation (EU) No 1223/2009 on cosmetic products.
In some cases, your product is required to have an Authorized Representative or Responsible Person before it can be placed on the European market.
Some basic obligations that the Authorized Representative must perform:

Before the product is released

  • Verify that the EU declaration of conformity and technical documentation have been drawn up.
  • Verify that the manufacturer has registered the information required in the EUDAMED (MDR/IVDR Article 11).

Products in circulation

  • Act on behalf of the manufacturer concerning specific duties related to the manufacturer’s obligations under the Regulation
  • Take the necessary corrective actions to bring the product into conformity, or recall the product, as appropriate.
  • Keep copies of all documents and provide them to the authorities upon request.
  • Cooperate with the authorities on preventive and corrective actions and immediately notify the manufacturer of complaints and requests from the authorities regarding product samples.
  • Liability for defective devices together with the manufacturer, if the manufacturer fails to comply with its obligations under the Regulation and is not located in the EU (Article 11(5) of the MDR/IVDR).