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EC Rep

If you want to sell medical devices in Europe, but your company does not have a physical location in Europe, you have to appoint an Authorised Representative. This has been laid down in the new Medical Device Regulation (EU) 2017/745 (MDR).

The obligations of the Authorised Representative

  • verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
  • keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate;
  • verify that the manufacturer has complied with the registration obligations;
  • in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device;
  • forward to the manufacturer any request by a competent authority;
  • cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
  • inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to the device;

 

EC Authorized Representation

Appoint Kinesis Medical as your Authorised Representative

By appointing Kinesis Medical as your Authorised Representative you comply with the Regulations and you will maintain independency. Contact us to find out more.

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