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UK regulator calls for EU committee to assess unforeseen risks/notified body responsibilities

This article was originally published in SRA

Executive Summary

Any discussion concerning the revision of medical device legislation in the European Union should include a careful assessment of measures that are intended to make devices safer but which may have undesirable repercussions that could threaten patient safety in an unanticipated way. This was the advice of senior UK device regulator Steve Owen when he spoke at the Medtec 2010 conference in Birmingham last month.

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