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French premarket delay plan - will it see the light of day?

This article was originally published in Clinica

Executive Summary

France has finally published the details of its plan that entails delayed market entry for some high-risk devices. The government has notified the European Commission and European Union member states about the range of products that will be subject to a requirement that will effectively mean a three-month delay for manufacturers. However, the plan will be found to be illegal on two counts, Paris-based consultant John McLoughlin told the Medical Device Technology European Conference in Paris last week.

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