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Reclassification of devices: lessons from joint implants case

This article was originally published in Clinica

Executive Summary

The EU needs a proper procedure for dealing with the reclassification of medical devices. That is the opinion of Steve Owen, head of European and regulatory affairs at the UK's Medicines and Healthcare products Regulatory Agency (MHRA). It comes in the light of experience over the handling, or as some would argue, mishandling, of the reclassification of hip, knee and shoulder implants from class II to class III to include a review of the design dossier.





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