EU Authorized Representative
The 2007/47/EU revision of the Medical Device Directive defines the European Authorised Representative as any natural or legal person established in the (European) Community who, as explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive.
MDCI is a founding member of the European Association of Authorized Representatives (EAAR) and maintains excellent relationships with Competent Authorities, Notified Bodies and trade associations. As your EU Authorized Representative, MDCI will:
- Communicate with EU Competent Authorities as your EUAR
- Verify that your CE mark is properly affixed and ensure that you comply with the appropriate Medical Device Directives and national transpositions
- Permit the use of the MDCI Ltd. name and address on your labeling as your European Authorized Representative
- Work with you to manage incident reporting to Competent Authorities
- Communicate with Competent Authorities about your clinical trials and, if applicable, any serious device incidents
- Prepare and submit any notifications and registrations to the appropriate Competent Authorities
Contact us to learn more about our European Authorized Representative (EUAR) services.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Client Testimonial
The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.
- International Trade Specialist at US Department of Commerce