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Danish DMA reallocates competent authority duty

This article was originally published in Clinica

Executive Summary

The Danish Medicines Agency (DMA) has reallocated the competent authority role for medical devices between its divisions. The main agency role, including applications for and approval of clinical trials for medical devices, will now be dealt with by the consumer safety division, headed by Elen Andersen. All inspectorate-type activities will be handled by the inspection, laboratories and enforcement division, under Anne-Marie Vangsted, including inspections required for clinical trials. The reorganisation effectively separates off the inspectorate and enforcement authority for drugs and devices from all the other regulatory responsibilities undertaken by the authority.

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