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More resources to improve the patient safety of medical devices

29 October 2019

Patient safety is to be improved by a threefold increase in staff and a restructuring of the agency’s Medical Devices Unit into four specialised teams.

These months, the Danish Medicines Agency's Medical Devices Unit is massively building up capacity in the medical devices area.

“Several stakeholders have for some time wanted us to build up our capacity within medical devices. Firstly, because the area of medical devices is changing fast; new products appear on the market constantly along with new technologies such as artificial intelligence and 3D printing, which are challenging the regulatory setup that we have today. Secondly, because new EU legislation enters into force in 2020, and that is inevitably going to require more resources from the authorities. 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”, said Thomas Senderovitz.

The new fee structure entered into force at the turn of the year and already means that the Danish Medicines Agency's budget for regulation and monitoring of the medical device market has increased considerably. It has long been the wish of politicians, patient organisations, doctors and other stakeholders to have a stronger and more specialised authority in this area.

The reinforcement means that the Danish Medicines Agency’s Medical Devices Unit will go from about 14 employees to about 40 employees once all new employees have been recruited in spring 2020. In addition, the unit is presently being restructured to accommodate four specialised teams in the future.

The four teams are:

  • Policy, coordination and international collaboration
    Among other things, this team will service the Medical Devices Committee and establish relations to other authorities, including agencies within the Minister of Health. The team is responsiblefor the Danish Medicines Agency's collaboration on medical devices in Europe and participates in working groups and the European network known as the Competent Authorities for Medical Devices (CAMD). 
  • Pre-market
    This team is responsible for enforcement of the rules on medical devices not yet on the market. This means control of notified bodies, approval of clinical investigation of new medical devices, applications for exemption, etc.
  • 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, collection of fees, export certificates, monitoring of medical devices, registration of incidents with medical devices and field safety corrective actions (FSCAs).

  • Market surveillance and user safety
    The last team is responsible for user safety and has authority to take products off the market in the last resort. The team reviews reports of device malfunction, failure and deficiencies, participates in the surveillance group, which discusses European problems with specific devices, and follows the development of new technologies, e.g. artificial intelligence, 3D printing, new software and health apps.

In addition, the Medical Devices Unit will work more closely with the Danish Medicines Agency’s division for Medicines Control & Inspection, which, among other things, carries out inspections of pharmaceutical and medical device companies. They will also work more closely with the Danish Medicines Agency’s division for Medical Evaluation, the division with the highest concentration of medical expertise in the Danish Medicines Agency.

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