NIC, as european authorized representative, serves as a liaison between the manufacturer and German Competent Authorities.
Manufacturers should also be aware that under Medical Device Regulation 2017/745 and IVD Regulation 2017/746, the EU Authorized Representative becomes fully liable for the manufacturer´s
Additionally, your EU authorised representative will:
• Support necessary registration and communication with European authorities and bodies
• Be identified on your product labeling throughout Europe
• Make a current copy of your Technical File and Declaration of Conformity available for inspection by a Competent Authority, upon request
• Assist with incident reporting and corrective action, in cooperation with you and your distributors