Health technology assessment (HTA) includes consideration of health and economic factors, playing a key role in optimizing healthcare provision in Europe. Medical devices are an important contributor to both health outcomes and the cost of healthcare provision, yet they are rarely addressed in current guidance for health-economic evaluation. Our aim is to help improve assessment of medical devices via review of European health-economic guidelines and recent research.

Searches for European HTA guidelines were performed and where available were reviewed by two researchers working independently. Additionally, a systematic review of published literature focused on assessment of medical devices was conducted. English, German, or French literature published between 2000 and 2017 was analyzed. The status of HTA guidance to date was subsequently reviewed in light of current research findings and suggestions made to help improve standardization.

Of the 41 investigated European countries, 22 had official HTA guidance. Only four of 22 (18 percent) dedicated documentation to guidance specific to medical devices. Where differences between pharmaceuticals and medical devices were highlighted, specifics for health-economic assessment of medical devices were generally absent. The systematic review yielded 472 unique articles, 28 of which underwent full-text review. Issues surrounding medical device value assessment that commonly emerged were: limited evidence base, learning curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. While identification of issues was ubiquitous, actionable suggestions on how to overcome them were less common. The most frequent recommendations were use of Bayesian methods, inclusion of real-world data, and modelling the learning curve. Key to implementation is determination of the medical device type and its impact duration.

Current guidelines rarely address the needs of medical devices. Practical recommendations for improvements exist and provide opportunity to start discussion on how best to serve the medical devices field and improve the HTA process.