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The extremes to which the French are going for ultra high-risk innovative products

This article was originally published in Clinica

Executive Summary

Just how far do the French authorities feel it is necessary to go to demonstrate the safety of products considered to be higher risk than all others? Catherine Defabianis, director of information and regulatory intelligence at A.R.C. Pharma (France) , gives details here of the new measures that the French national agency for healthcare product safety ANSM put forward to the country's parliament in late October for those ultra high-risk medical devices

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