Authorised representatives of medical devices do not always meet the basic requirements

Authorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European Union. The Dutch Health and Youth Care Inspectorate (IGJ) supervises authorised representatives based in the Netherlands of medical devices manufacturers. In 2022-2023, the IGJ inspected 24 authorised representatives acting on behalf of more than three manufacturers in relation to specified tasks with regard to the latter’s obligations under the MDR/IVDR. This publication aims to inform readers about the results of these inspections carried out.

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Where a manufacturer of a medical device is not established in a European Member State, the medical device may only be placed on the Union market if the manufacturer designates a sole authorised representative.

The authorised representative is responsible for representing the manufacturer and falls under the supervision of the inspectorate in the EU Member State where the authorised representative is located. European Regulations MDR and IVDR set out the legal requirements that authorised representative have to meet. 

A single authorised representative may represent an unlimited number of manufacturers and medical devices. Some represent more than 50,000 medical devices. Inspectorates within the EU do not have direct supervision over the original manufacturers outside the EU, which stresses the important of the supervision of authorised representatives.

The IGJ conducted its assessment on the basis of three key themes: 

  • the mandate between the authorised representative and the manufacturer
  • the knowledge and experience of the Person Responsible for Regulatory Compliance (PRRC) of the authorised representative
  • the responsibilities of the authorised representative in respect of the manufacturers they represent

The IGJ aims to achieve better compliance with the requirements of the MDR/IVDR on the part of authorised representatives through this publication. That’s why the IGJ outlined specific actions for improvement for all authorised representatives.