European representative service

European regulations require the identification of a representative for all manufacturers that have a head office outside the European Union.

The European representative ensures the following responsibilities:

  • Keep the technical documentation, the declaration of compliance and, if applicable, a copy of the certificate in force and any additional document, at the health authorities’ disposal
  • Cooperate with the health authorities for any corrective measure to be taken to remove any risks posed by devices
  • Immediately inform the manufacturer of any complaints and notifications by health professionals, patients, and users relating to presumed incidents involving a device that it represents

We provide this service and ensure you a high standard of service and follow-up.

This service is subject to an annual set fee