The past 7 months were certainly challenging as we endeavored to write procedures, train out employees and implement our 9001 system, however, this task would have been impossible were it not for your supervision, your guideance and your sense of humour. Words alone cannot convey our true sense of appreciation. We wish you continued success in your ISO consulting business and we will heartily recommend your firm to anyone who approaches us seeking such services.-TP Composites

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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 

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