European Authorised Representative
How BS Partnership can be your EU Representative for CE Marked Products within Europe.
European Representative
Every CE Marked Medical Device and In Vitro Diagnostic Medical Device manufactured outside of Europe must have a European Representative (EU Rep) by law. The EU Rep is then the first point of contact between the regulatory authority and the foreign manufacturer. The EU Rep must answer any questions posed by the regulatory body in the event of an issue with a device.
Services WE USUALLY OFFER:
I. Liaise with the Notified body or Competent Authority on your behalf
II. Register the your Company's products with appropriate Competent Authorities
III. Participation in the reporting of Adverse Incidents to Competent Authorities
IV. Regularly reporting on issues affecting your current compliance
V. Assistance in establishing and monitoring product feedback for regulatory responsibilities.
VI. Regulatory Affairs Technical Support
