OBJECTIVES: Historically, reimbursement decision-making for medical devices in Europe has been decentralized, creating inefficiencies in review and delaying patient access. In response, EUnetHTA has developed a framework enabling a Joint Clinical Assessment (JCA) for medical devices. This study sought to understand the impact of the JCA across Europe and analyze the JCA’s impact on manufacturer evidence development strategies.

METHODS: A targeted literature review evaluated how the JCA will impact country-level decision-makingSources included PubMed, the ISPOR database, and gray literature (e.g., EUnetHTA publications). Qualitative interviews with industry leaders to gather perceptions of the impact of the JCA on evidence-generation planning.

RESULTS: We identified 98 relevant sources; five manuscripts (PubMed), 88 posters or presentations (ISPOR), and five EUnetHTA publications. Material review identified multiple uncertainties that may slow or JCA imp, including inconsistencies in definitions of standard of care (SoC) and unmet needs, disparities in typical evidence for medical technologies versus pharmaceuticals, and applicability across European markets. Inconsistency in the representation of unmet needs may result from patient and healthcare professional inputs on SoC across countries, and the medical technology industry has traditionally relied on single-arm studies and real-world evidence, not randomized controlled trials with comparators. Finally, each country’s health technology assessment

CONCLUSIONS: The JCA mandate is to streamline the clinical evaluation of medical technologies; however, our findings indicate it currently does not address critical components of product value, including economic and societal impact, which play an essential role in reimbursement evaluations for medical devices. As JCA is rolled out, medical device manufacturers must be vigilant of changing requirements and evolving evidence needs.