OBJECTIVES: Coverage with evidence development (CED) schemes have been proposed for reducing the decision uncertainty surrounding new health technologies. In principle, medical devices are good candidates for CED, since the clinical data available at market entry are often sparse and cost-effectiveness in real-world use is often dependent on user skills and organizational characteristics. However, experience with CED to date is predominantly with pharmaceuticals. The objective of this research was to explore the challenges with CED schemes for devices and how these challenges are being tackled in EU member states.

METHODS: Based on a systematic literature review, we identified 13 challenges relating to study design, data collection, monitoring and implementation of CED schemes. We then surveyed policy makers responsible for medical device appraisal in EU member states, to obtain details of CED schemes for medical devices in their jurisdiction, to determine their views about the various challenges, and to ascertain how these have been tackled in any existing schemes.

RESULTS: Policy makers from 20 countries agreed to be interviewed, and 8 of them reported on existing schemes for devices. The procedures to initiate, implement and monitor CED schemes vary across countries, including the eligibility criteria, type and roles of the stakeholders involved, funding arrangements, and the mechanisms to implement policies based on study results. Overall, policy makers agreed that device characteristics, such as the existence of a learning effect, short product life cycle and incremental innovations require particular attention when determining the desirability and design of schemes. However, no explicit guidelines exist on how to address these characteristics.

CONCLUSIONS: the results obtained should help policy makers to anticipate the likely challenges in CED schemes and to identify aspects of good practice in the design and implementation of schemes that they could follow in their own jurisdiction.