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Caution urged in Medical Devices Directive review

This article was originally published in Clinica

Executive Summary

While there are calls from legislators throughout Europe to use the current five-year review of the European Union's Medical Devices Directive (MDD) to tighten requirements for testing and certification bodies, some sections of industry are starting to advocate more caution. Calls for only a few amendments to the MDD, not a universal overhaul, and for regulators to be circumspect about increasing the depth and intensity of notified body assessments are beginning to be heard.





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