OBJECTIVES: The regulatory process for approving new medical devices in Europe is clear; a CE mark indicates that products have been assessed and deemed to meet EU safety, health and environmental protection requirements. However, funding and reimbursement pathways vary by country. This research explores how pathways for funding and reimbursement across Europe influences uptake for medical devices.

METHODS: We performed secondary research to examine the public funding and reimbursement pathways in three countries; France, Germany, and Spain.

RESULTS: In France, each hospital has a committee that decides on formulary inclusion of a device. Procedures associated with the device are described on a national diagnosis related group (DRG) list, for which each procedure has a corresponding tariff. Innovative devices can be included on the Liste des Produits et Prestations Remboursables (LPPR), through a positive health technology assessment (HTA). Germany has two different funding routes; inpatient procedures are funded at federal level based on a DRG system, whereas outpatient procedures are included in the Einheitlicher Bewertungsmassstab (EBM) list after a positive HTA. Reimbursement in the outpatient setting is more complex, with funding coming from the Statutory Health Insurance on a fee-for-service basis, instead of the DRG budget. In Spain medical devices need to get a national product code assigned by the Spanish Medicines Agency. Funding is based on a DRG system which can happen at national level. However, Spain has 17 autonomous regions which have the authority to decide differently through regional executive and legislative mechanisms. In each country, clinical opinion is valued through the decision-making process therefore clinicians are key stakeholders for driving uptake for new devices.

CONCLUSIONS: The process to maximise uptake of new medical devices is complex and early stakeholder involvement is recommended to support value demonstration. The creation of tailored strategies per country is required to optimise opportunities for medical devices.