Who pays for your device? Reimbursement and market access in Europe
A medical device company that has just received its CE certificate often expects sales to follow. In practice, the first question a hospital asks is not whether the device is approved, but how its cost will be covered. The answer is different in each European country, and it decides how fast a product can grow. That is why market access work should start long before the launch.
Three questions every payer answers
Whatever the country, a payer looks at a new device through three questions. Can the procedure be recorded in the national coding system? Is there a payment that covers it, for example a hospital tariff or a diagnosis-related group (DRG)? And has the buyer, whether an insurer, a region or the hospital itself, agreed that the extra cost is justified? In market access work these are usually called coding, coverage and payment. A device can have a code and still lose money for the hospital if the payment does not reflect its price.
In hospitals, the device usually sits inside the DRG
Most European hospitals are paid per case through a DRG system. The price of an implant or a disposable is not paid separately; it is part of the fixed amount the hospital receives for the treatment. A more expensive device therefore reduces the hospital's margin unless it shortens the stay, prevents complications or allows a cheaper procedure.
Several countries have temporary routes for innovations that do not fit an existing DRG. In Germany, for example, hospitals (not manufacturers) can apply to the InEK institute by 31 October each year for a NUB payment for a new method. If the method is accepted, each hospital negotiates its own time-limited supplement with the payers. A manufacturer cannot apply itself, so it needs hospitals that are willing to do the work.
The Nordic countries work differently
The Nordic countries have no national list of reimbursed hospital devices. Hospitals are run by regions, or in Finland by wellbeing services counties, which buy devices from their own budgets, mostly through public tenders. Finland, Sweden and Norway use DRG systems based on NordDRG. National bodies give advice on which technologies should be used:
In Finland, the Council for Choices in Health Care (COHERE) advises on which services should be publicly funded, and FinCCHTA coordinates national and hospital-based health technology assessment.
In Sweden, the regions' Medical Technology Products Council selects devices for national evaluation, the Dental and Pharmaceutical Benefits Agency (TLV) carries out the health economic analysis, and the council then recommends to the regions whether to use them.
In Norway, devices can be assessed in the Nye metoder system, where the chief executives of the four regional health authorities decide on introduction in specialist care.
In Denmark, the regions set up the Danish Institute for Quality in Healthcare (SundK) in January 2025. Its council took over the work of the former Danish Health Technology Council and recommends to the regions whether new technologies and treatments should be introduced.
For a manufacturer, this means the customer and the payer are often the same: the region's procurement unit and its clinical leaders. A positive national recommendation helps in a tender, and a negative one can close a market for years.
A common European assessment has started
The EU Health Technology Assessment Regulation has applied since January 2025 and introduces joint clinical assessments at EU level. For devices, these cover selected class IIb and III devices and class D in vitro diagnostics that have received an expert panel opinion during certification, and that meet at least one of the selection criteria, such as an unmet medical need. On 6 October 2026 the Commission announced its first selection: two transcatheter mitral valve replacement systems. The Commission publishes each new selection in its JCA tracker. A joint assessment describes the clinical evidence, but it does not decide pricing or reimbursement. Those decisions remain national.
What to prepare before entering a market
A market access plan answers a few practical questions for each target country. Who decides on the purchase, and from which budget? Which procedure codes and DRGs apply today, and how much of the device's price do they cover? Has a national body assessed this or a similar technology, and what evidence did it ask for? When are coding and tariff updates published, and how long does a change take? The answers often show that the order of countries in a business plan should change, or that a study should collect economic data in addition to clinical outcomes.
At HealthChain we combine market selection and distributor work with input from reimbursement and market access specialists in our network. The aim is a realistic view of how, and how quickly, a device can be paid for in each market before money is spent on entering it.
If you are deciding where to launch in Europe and how your device will be paid for, book a 30-minute call.
