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