The Danish Medicines Agency provides regulatory guidance on the EU regulations MDR, IVDR and AI Act

The medical device industry is growing fast. With the new rules for MDR, IVDR and the upcoming AI Act, there is a particular need for guidance in this area. The AI Act will apply from August 2027 to medical devices with high-risk AI systems. In this connection, requirements will be imposed on manufacturers and operators of medical devices with AI. 

In this connection, the Danish Medicines Agency has decided to offer one-on-one meetings to startups and small and medium-sized medical device manufacturers as well as educational and research units. Danish companies are defined as companies with headquarters in Denmark.

The Danish Medicines Agency's purpose with the guidance is to help companies get started and support the development of safe and innovative devices that can benefit patients. It is also intended to support the government's growth plan for life sciences. 

The regulatory guidance includes detailed guidance on applicable EU regulations, including the MDR, IVDR and AI Act, as well as guidance on applications for clinical trials. This may include CE marking, clinical evaluation requirements, and clinical trials. However, the guidance does not cover 1) Classification of devices 2) Approval of medical devices 3) Specific assessment of documents that are part in an application for clinical trials 4) Take position on specific issues or other matters where the Danish Medicines Agency may make a decision 5) Commercial issues and scientific advice 6) Consultants and private advisors are not covered by this concept.

The guidance is based on current knowledge in the field. It is therefore not binding on the Danish Medicines Agency in relation to subsequent decisions in specific cases. 

The meeting can be booked by filling out a meeting request form and sending it to their email address for regulatory guidance, which both can be found on the Danish Medicines Agency´s website. The meeting can either take place physically at the Danish Medicines Agency or virtually. The Danish Medicines Agency expects to be able to confirm a meeting date within 14 days. The Danish Medicines Agency has made several videos about the regulatory guidance, which can be viewed on the Danish Medicines Agency's website.