EU Authorised Representative

EUAR

When a medical device manufacturer is established outside of European Union, the manufacturer needs to appoint an authorised representative to place a medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer.
A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory. The authorised representative must provide a copy of the mandate to the competent authority when requested.
The authorised representative shall perform the following tasks specified in the agreement between it and the manufacturer.

  • To represent the manufacturer towards the European Commission, Authorities and Notified Bodies.
  • To verify that the EU declaration of conformity and technical documentation of the device is up to date and appropriate conformity assessment has been carried out by the manufacturer.
  • To keep available a copy of the technical documentation, the EU declaration of conformity and a copy of the relevant certificate for inspection by European Competent Authority.
  • To register a device with the national databases before they are marketed.
  • To provide necessary information and documentation to demonstrate conformity of the device in response to a request from a competent authority in an official Union language determined by the Member State concerned.
  • To forward to the manufacturer any request by a competent authority of the Member State for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
  • To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
  • To immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device.
  • To ensure the device is compliant with updated regulations and advise manufacturers on updates of European regulations.
  • To terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

How we assist you with this process?

  • Act as your EU Authorised Representative
  • EUDAMED registration
  • Local country registrations

Why Choose Us  

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk