Navigating the regulatory landscape for medical devices is complex, especially in relation to using clinical study data from overseas to support regulatory approval and reimbursement in the U.S., EU and U.K. The key question many companies face is whether their completed clinical study in another country can be leveraged for regulatory processes in these regions. While it is possible, the answer is nuanced and depends on various factors such as specific indications, risk-benefit profiles, and the type and scope of clinical data.
In this comprehensive analysis, we delve into the intricacies of regulatory acceptance in these three major markets and examine primary considerations, including the role of individual reviewers, the ambiguous regulatory terminology and the subjectivity involved in the interpretation of data.
The acceptance of overseas clinical data fundamentally hinges on the compatibility between regulatory jurisdictions. We break down this compatibility into four principal areas:
- Jurisdiction: Alignment of regulations and laws, including mutual recognition and good clinical practice.
- Demographic and Clinical Representativeness: Reflecting the population of the target country in the clinical data.
- Clinical Relevance and Standard of Care: Compatibility with accepted medical practices.
- Quality Standards and Performance Requirements: Compliance with specific device-related standards.
Meeting these criteria is challenging, and the specifics of your device and study design play a critical role. Engaging early and thoroughly with regulatory bodies and understanding the regulatory landscape are crucial steps. Additionally, aligning clinical data efforts with reimbursement requirements from government and private payers is essential.
For a detailed analysis and tailored recommendations on how to navigate these complexities and effectively utilize your clinical data assets globally, download the full article by Gwilym Owen, Kory Dillman and Marty Culjat.
Contact EVERSANA’s team of regulatory experts to learn more about how we can support your regulatory strategy and help you achieve compliance across multiple markets.
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Author
Gwilym is a seasoned regulatory professional with 15+ years of experience in Software as a Medical Device (SaMD). His expertise spans startups to large corporations, covering manufacturers and distributors. Gwilym has contributed significantly to…
With over 25 years in business and technology operations, Kory brings a wealth of experience to the ever-evolving medical device field. He partners with companies developing medical devices, leveraging his deep understanding of global…
Marty Culjat, PhD is the SVP, Global Head of Digital Medicine & Regulatory Innovation at EVERSANA. In this role, he leads a cross-functional team supporting the commercialization of digital medicine products within companies ranging…