10 Pragmatic Points to Consider When Performing a Systematic Literature Review of Clinical Evidence on Digital Medical Devices

Abstract

Innovative Digital Medical Devices (DMDs) are gaining a growing importance in healthcare, thus the interest regarding their actual clinical value is increasing. Gathering and evaluating all available clinical evidence on a device is needed for the developers, manufacturers, notified bodies (certification), product managers, clinicians and, above all, for the users. Systematic Literature Review (SLR), is a scientific, standardized method, often used to identify and evaluate all available evidence on a relevant question, hence this method is widely used and accepted to provide high-quality evaluations on clinical evidence. Moreover, the Medical Device Regulation (EU 2017/745) also considers clinical evidence derived from the peer-reviewed scientific literature for the assessment of medical devices being adequate, considering even sustainability aspects. Researchers therefore can actually contribute to the clinical assessment of novel DMDs through the rigorous assessment of the State-of-the-art and the comprehension of the existing levels of evidence. Although the methodology of SLRs has been established in the past decades, some specific questions arise when it comes to DMDs. The objective of this paper was, therefore, to establish a set of practical points to consider in SLRs of clinical evidence on DMDs. We believe that our work helps to speed up DMD development, authorization, management and implementation, thereby eventually, contribute to the health of patients.