MedR-AR Services B.V
EAR Services
EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES
We are offering a set of Authorized Representative services under the Medical Device Regulation 2017/745 (MDR)
Our MedR-AR services will provide you with a European Authorized Representative that will serve as a liaison between you, the European Commission and the National Competent Authorities
EU Authorized Representative under the Medical Device Regulation 2017/745
When a manufacturer of medical devices is not established in a European Member State, it is a legal requirement to designate a European Authorized Representative (AR). The European Authorized Representative will be the point of contact between the manufacturer, the European Commission and the National Competent Authorities.
The European Authorized Representative takes on responsibilities as defined under the Medical Device Regulation 2017/74 and per manufacturer’s mandate.
MedR-AR Services B.V. can support you in as AR for:
Authorized contact with EU Authorities
Authorized contact for importers and/or distributors
Verify conformity of your Technical Documentation and Declaration of Conformity
Verify conformity of your labeling
Vigilance and Field Safety Corrective Action reporting
Medical device market registration and Approval support
Free sale Certificate, including legalization
