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EU 25: regulatory crisis of confidence looms

This article was originally published in Clinica

Executive Summary

There could be a new crisis of confidence in the European medical device regulatory system next year with the advent of the 10 new member states to the EU, unless the regulators agree to new inspection activities to ensure this is averted. That was the thrust of the message put forward by Malcolm Carlisle, group managing director at Eschmann Holdings at the 11th Annual ABHI Conference on Medical Device Regulation.

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