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Voluntary inspection of GLP activities of safety studies involving medical devices

08 March 2011

Due to changes to the division of work between the Danish Accreditation and Metrology Fund (DANAK) and the Danish Medicines Agency related to inspections of good laboratory practice (GLP), the Danish Medicines Agency will in future be inspecting GLP trials of medical devices.

The decision has been made on the basis that the task links naturally with the Danish Medicines Agency's other tasks of inspecting manufacturers of 'class 1' devices, monitoring device manufacturers as well as authorising and inspecting trials of medical devices in humans.

Our inspections of GLP trials of  medical devices will be conducted as voluntary inspections since there is no specific legal basis for such inspections.

Companies that would like the Danish Medicines Agency to perform an inspection, must submit a written request to the Danish Medicines Agency, Medicines Control Division, Department of Planning & Development.

We will then notify the company of the scheduled date for inspection and of the expected costs. The company will be charged the actual travel expenses plus an hourly rate of DKK 700 per participant of the inspection team.