New French regulations could fall outside European law
This article was originally published in Clinica
The European Commission has warned France that it will break European law if it goes ahead with plans to implement strict new regulatory requirements for high-risk medical devices. The Commission told French officials in late April that it could not introduce a blanket measure to force companies to give three months notice of their plans to launch high-risk products, as that would be disproportionate to the potential risks.
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