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MDA (UK Medical Devices Agency) plans for growing regulatory enforcement remit

This article was originally published in Clinica

Executive Summary

The UK Medical Devices Agency (MDA) expects its workload to continue expanding over the coming year, especially in the field of regulatory enforcement. According to its business plan for 2000-01, the primary drivers of this trend will be the extension of manufacturer registration requirements, expansion of the audit programme of UK notified bodies to include those involved with new regulations for in vitro diagnostic devices (IVDs) and an increase in the number of alleged breaches of the medical devices regulations.

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