European Ombudsman suggests Commission needs more robust evidence when reclassifying medical devices

BY COREY JASEPH, MS, RAC

The European Ombudsman recently updated its investigation into the complaint that the Commission reclassified brain stimulation devices without a thorough look at the scientific evidence. But the advice went beyond the specific instance of the reclassification regulation to suggest that the regulator needs to ensure its feedback mechanisms are robust and thorough.

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