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European industry puts up strong fight with regulators over implants

This article was originally published in Clinica

Executive Summary

The EU medical devices industry has built a strong case to oppose any proposals for fundamental changes to the EU Medical Devices Directive during its current five-year review. It is very worried about proposals that have been put forward by some EU competent authorities, which could have far-reaching consequences for manufacturers, particularly those concerning the reclassification of most implants from Class IIb to Class III.

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