Danish Medicines Agency Ramps Up Capacity in Medical Devices

Regulatory NewsRegulatory News | 29 October 2019 |  By 

The Danish Medicines Agency's Medical Devices Unit is “massively building up capacity” in the area of medical devices, the agency said Tuesday, to better deal with the incoming EU device legislation and to address rapid changes in technological development.

A new fee structure will allow the devices unit to increase its staff capacity from about 14 employees to about 40 employees once all new employees have been recruited next spring. The unit will also work more closely with the Danish Medicines Agency’s division for Medicines Control & Inspection and the division for Medical Evaluation, which contains the highest concentration of medical expertise.

“Over the past years, we have therefore worked to get the necessary funding in place to increase our capacity, and we are very pleased to have now succeeded,” Thomas Senderovitz, director general of the agency, said in a statement.

The device unit will also be restructured into four units:
  • Policy, coordination and international collaboration: This team will help the Medical Devices Committee and establish relations with other authorities, including agencies within the health ministry. The team is responsible for agency’s work on medical devices in Europe and with the European network known as the Competent Authorities for Medical Devices (CAMD).
  • Pre-market: this team will enforce the rules on devices not yet marketed via the control of notified bodies, approval of clinical investigation of new medical devices and applications for exemption, among other tasks.
  • Data and operation: This team is responsible for tasks linked to medical devices already on the market. This means registration of manufacturers on the Danish market, the collection of fees, export certificates, monitoring of devices, registration of incidents with devices and field safety corrective actions.
  • Market surveillance and user safety: This team is responsible for user safety and has the authority to take products off the market. The team reviews reports of device malfunctions, failures and deficiencies, participates in a group on surveillance, which discusses EU problems with specific devices, and follows the development of new technologies, including artificial intelligence, 3D printing, new software and health applications.
The Danish Medicines Agency also said in August that it's a launching a new pilot project on regulatory advice for startups and small and medium-sized device manufacturers related to the new EU regulation taking effect next May.

The agency previously worked with the World Health Organization to build up drug and medical device regulatory authority capacity in low and middle-income countries.

Danish Medicines Agency


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