Barriers and facilitators for digital health medical device registration in the UK: A scoping review
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Background
Digital technology within healthcare has dramatically expanded in recent years, particularly with the growth of the use of medical or health-related apps. With this expansion comes the need for regulation and certification; however, the regulation process has many barriers. No review has examined the barriers and facilitators for stakeholders who aim to register software as a medical device.
Methods
The review was structured using the PRISMA extension for Scoping Reviews and PICOS framework. Studies were retrieved from five databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Scopus. A descriptive analysis provided an overview of the barriers and facilitators to the registration of digital health solutions as medical devices in the UK.
Results
A total of 9 studies met the inclusion criteria and were included in the analysis. Of the 9 studies, the most common were perspective papers (n=4), with the remaining consisting of qualitative research (n=1), case studies (n=2), a development framework (n=1) and a debate paper (n=1). 4 of the 9 studies discussed any digital technologies, 3 discussed mental health apps, and the remaining 2 studies discussed a range of open-source hardware, mobile health care technologies and mental health apps. The analysis identified a range of barriers, including complexity, lack of clarity - particularly in what constituted a medical device - and a lack of tailoring of the process to specific characteristics of digital health technologies. The process of registration was described as confusing and complex. Analysis of facilitators highlighted several guidance documentations to support registration and a tiered approach to registration based on the intended use and risk level. Some studies highlighted potential ways to improve the process, including templates and examples approved by notified bodies, medical device certification training, and greater evidence-generation flexibility.
Conclusions
This review highlights the importance of clarity and specificity in definitions and guidance for registering and regulating digital health technologies. It also opens avenues for further discussion on levels of influence of registration barriers on patients, healthcare professionals and other end users to reflect user needs in registration. Further exploration of registrations with other regulatory jurisdictions and real-life cases of registration are still required to extend the understanding of barriers to registration beyond the UK context.
Author Summary
This review explored the challenges to stakeholders in the registration of digital health technologies as medical devices in the UK. We identified a few key challenges: complex registration regulations, unclear definitions of medical devices and clinical validation, and a lack of clinical evidence requirements for digital health technologies. These challenges would make it difficult for stakeholders to determine if their software qualifies as a medical device and how to demonstrate its safety and efficacy. High costs associated with registration and complex clinical validation requirements are particularly challenging for startups and SMEs, given their limited resources and experience. Existing guidance and tiered classification of medical devices facilitate the registration process to some extent, but not sufficiently for stakeholders without relevant expertise. To facilitate the registration process, we encourage templates and examples from approved bodies for medical devices, as well as tailored guidelines of device registration for different types of digital health technologies.
