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MDA (Medical Devices Agency) promises tough action to safeguard EU device regulation

This article was originally published in Clinica

Executive Summary

The Medical Devices Agency is tackling head on the main focus of the criticism levelled at the European medical device regulations, the notified bodies (third-party assessors of devices), by taking draconian action where it identifies areas of concern. In the year 2001-02, it suspended a number of individual assessors while they were retrained and prevented certain notified bodies from dealing with some types of products or from taking on new customers until the problems had been fully addressed.

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