MDR and IVDR in Danish regions and municipalities

12 January 2023

In May 2021, a new EU regulation on medical devices (MDR) came into force and on 26 May 2022, the EU regulation on in vitro diagnostic medical devices (IVD-R) became effective.

The regulations provide a new and stricter framework for medical devices used by, for example, regions and municipalities, to ensure they are safe for the public and healthcare professionals.

Medical devices, including in vitro diagnostic medical devices, are products which are used to diagnose, prevent, relieve or treat a disease, disability or injury. There are more than 500,000 different types of medical devices, which are divided into different risk classes.
Medical devices are widely used in regions and municipalities and include, for example, wheelchairs and other aids, feeding pumps, equipment for measuring vital signs, dentistry equipment, software, various scanners, etc.

Therefore, the Danish Medicines Agency has launched a number of initiatives to provide advice and guidance on the regulations, through a dialogue meeting with the regions in April 2022 and workshops for the municipalities in the second half of 2022.

In the below subsections, you will find material from the dialogue meeting with the regions and the workshops with the municipalities.