npj Digital Medicine (Oct 2024)
Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning
Abstract
Abstract Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable gaps in maturity levels, cross-country learning effects are becoming prevalent. We expect more countries, both within the EU and beyond, to follow the steps of current frontrunners, hence expediting the harmonization process.