OBJECTIVES: Coverage with evidence development (CED) is increasingly being used to provide provisional coverage for promising, but unproven, interventions, while additional data are generated. This study aimed to explore the application of CED in the context of devices. METHODS: First, a literature review was conducted on international CED schemes and the CED approach more generally. In total, 50 articles were gathered and reviewed. Second, semi-structured telephone interviews were conducted with different expert groups (payers/HTA bodies, industry, and academics/policy analysts) to better understand the use of CED in different jurisdictions; identify and explore device CED case studies; and, gather expert opinion on the challenges associated with the CED approach and potential strategies to improve current policy and practice. A total of 25 experts were invited to participate, of which 20 (80%) agreed and were interviewed. RESULTS: Canada, the UK, and US have the most experience with CED applied to devices; Germany and the Netherlands have both recently introduced new CED policies for devices and procedures. Devices that have undergone CED in these jurisdictions include ICDs, stents, TAVI, laparoscopic surgery, and spinal cord stimulators. While there are distinct differences in the national approaches to CED, common challenges were identified: 1) establishing a clear framework for initiating, overseeing, and stopping CED studies, 2) identifying and applying appropriate study methods, 3) funding CED studies, 4) incentivizing studies, and 5) applying new evidence to inform coverage decisions. CONCLUSIONS: Devices are viable candidates for CED, given some of their unique characteristics and often uncertain evidence base at the time of coverage determination. However, improvements are needed, including enhanced clarity and predictability of CED selection criteria and processes, greater stakeholder collaboration, new models to fund studies and collect data, better incentives for physicians to engage in studies, and strengthened requirements for use of new evidence in coverage policies.