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EU medtech experts highlight need to get a grip on guidance

This article was originally published in RAJ Devices

Executive Summary

The over-reliance in the European Union medtech sector on producing non-mandatory guidance documents at the expense of legally enforceable regulations has led to a lack of consistency among EU member states in implementation. It is also leading to fragmentation and to a lack of credibility in the sector and the situation needs to be addressed urgently, according to senior UK devices regulator Steve Owen.

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