European regulation (MDR 2017/745) requires the identification of an authorized representative for all manufacturers based outside the European Union.

The European representative has the following responsibilities: 

• Keep the technical documentation, the declaration of conformity and, if necessary, a copy of the applicable certificate and any additional document, available to the competent authorities

• Cooperate with competent authorities on all corrective measures to be taken to eliminate the risks posed by devices

• Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users regarding suspected incidents related to a device included within its contract

We provide this service by ensuring a high level of service and monitoring.

This service is subject to an annual package.

Contact us for support with our partner