✿The AR shall perform the tasks specified in the mandate agreed between it and the manufacturer.
✿ Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed representative will:
✿ Assist with certain device registrations, as required.
✿Be identified on your product labeling throughout Europe.
✿Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request.
✿ Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors.
✿The role of a European Authorized Representative is both varied and challenging. The main duties include, but are not limited to, the following:
✿Providing a registered address within the European Union
✿Keeping all technical documentation available for inspection by the European Authorities
✿ Completing notifications to European Authorities
✿ Completing any registrations to national databases
✿ Taking care of any incident reporting
✿ Representing the manufacturer towards the European Commission, Authorities and Notified
✿ Safeguarding and ensuring compliance with constant regulatory updates
✿ Consulting on European Regulations