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Market access for medical technologies in Denmark

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Denmark

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Key topics

There are three key themes describing market access for medical technologies in Denmark: 

  • Reimbursement: payment mechanism via the DRG-adjusted budget system
  • Funding: national recommendations from the Health Technology Council
  • Health technology assessment: obtaining recommendations from the national and local HTA bodies
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Reimbursement

Denmark uses the Danish DRG system, but hospital revenue from the DRGs accounts for only about 20%. Hospital care is predominantly funded via a global budget mechanism, which is mostly calculated based on actual costs incurred by the hospitals (differences in calculation methodology among regions may exist). 

However, all inter-regional care is reimbursed on a case-by-case basis via the DRG system. Therefore, the role of DRG is higher for procedures, which are concentrated only in several hospitals across the country and which provide care for patients from other Danish regions. 

DRGs are determined by the combination of a procedure code (SKS) and a diagnosis code (ICD-10). The SKS nomenclature and the Danish DRG system are maintained by the Health Data Authority. 

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Funding

Denmark has no nationally defined list of health benefits which are guaranteed to the Danish population. Decisions on which treatment methods to use and which new technologies to introduce are made by the hospitals.

Danish regions have a system to collaborate on the introduction of medical technologies and to enable equal access, cost-effective and efficient use of medical technologies in the country. In this framework, technologies are evaluated on the national level by the Health Technology Council, which provides recommendations for the adoption of novel technologies to payers (Regions) and healthcare providers. 

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Health technology assessment

HTA is performed on the national level (as part of the evaluations by the Health Technology Council) or on the regional and local levels (two organizations have limited activity in the Med Tech space). 

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Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. IVD tests are funded using a global budget principle as part of the laboratory funding.

MTRC has experience with more than 150 projects in Denmark

News and insights

Possibility of reprocessing and further reuse of single-use medical devices approved in Denmark

On January 1, 2025, an amended Executive Order on Medical Devices entered into force, which makes it possible to send single-use medical devices for reprocessing and further reuse. At the same time, it ensures that the reprocessed devices are safe and effective to use on an equal footing with the original CE-marked devices.

The Danish Healthcare Quality Institute is in place from January 2025

Since January 1, 2025, the Danish Healthcare Quality Institute has been established, replacing the Health Technology Council and the Regions' Clinical Quality Development Program. The Institute comprises three overall focus areas that contribute to patients receiving high and uniform quality treatment across the country and the best possible health for the money.

A regular update of the Danish SKS coding system from January 2025

The Danish Health Data Authority quarterly updates the Health Care Classification System (SKS). The latest version was published in mid-December 2024 to come into force on January 1, 2025. Among other changes, thirty-two new procedure codes were introduced concerning diagnostic imaging, endoscopy, ENT, gastrointestinal, in-vitro diagnostics, neurology and neurosurgery, neuromodulation, surgical procedures, mental health, and some other fields.

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