Although BRA is a central pillar of medical device regulation, the study shows that approaches remain fragmented and often rely on qualitative or semi-quantitative assessments. Regulatory agencies such as the FDA and EMA employ structured qualitative frameworks, while more quantitative methods, such as multi-criteria decision analysis (MCDA) and advanced modelling techniques, are also in use. However, these approaches are inconsistently applied, rarely device-specific, and lack universal alignment.
The review highlights several persistent challenges:
- limited transparency in decision-making processes,
- difficulties in systematically including patient perspectives
- insufficient integration of real-world evidence.
Notably, cybersecurity considerations, an increasingly critical factor in connected medical technologies, remain under-addressed in most existing methodologies.
The authors conclude that while methodological tools are available, the absence of a universally accepted framework undermines the robustness of BRA across the medical device lifecycle. They call for more transparent, standardised, and adaptive methodologies that can be tailored to different device types and keep pace with emerging technologies.
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Cover photo credit :Tima Miroshnichenko