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EU member state opposition grows against medical device 'scrutiny' procedure

This article was originally published in SRA

Executive Summary

'Almost all' member states representatives at the Council of the European Union believe the contentious 'scrutiny' procedure for high-risk and innovative medical devices as proposed by the European Commission would be impossible to apply1. That is according to a progress report that the Italian Presidency of the Council of the EU has prepared on the proposed medical device and IVD regulations for the 1 December meeting of the Employment, Social Policy, Health and Consumers Council.

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