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EU devices regulation: steady moves forward or kneejerk reactions?

This article was originally published in Clinica

Executive Summary

Should there be a major failure by a notified body in the next couple of years, it will call into question the entire medical device regulatory system. And this will accelerate major changes in the regulations as we know them today, writes Amanda Maxwell. That was view of Mika Reinkainen, managing director of the newly-established consultancy, Abnovo, at the regulatory sessions of the Medtec UK 2008 conference held in at the NEC, Birmingham, on February 13-14.

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