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Notified Bodies, Authorized Reps And The CE Mark: Post-Brexit Uncertainty Clouds Future Regulations

This article was originally published in The Gray Sheet

Executive Summary

The soon-to-be-adopted Medical Device and In Vitro Diagnostic Regulations in the European Union are expected to take effect in the next three to five years, when the UK could be separate from the EU. What are the potential regulatory implications of the "Brexit" for device firms in the UK and throughout Europe?

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