INTRODUCTION: The use of medical devices (MDs) carries both benefits and risks. Regulatory frameworks mandate the weighing of both through a benefit-risk analysis (BRA). This review aims to identify existing BRA methodologies and evaluate their strengths and weaknesses to evaluate their sufficiency in guiding developers and regulators.

METHODS: A literature search following PRISMA-S was conducted in five databases. Peer-reviewed publications were included when they described BRA methodologies for MDs. Publications on unrelated technologies, pharmaceuticals, non-English publications, and with insufficient descriptions were excluded. The methods were summarized and assessed for their degree of objectivity and for the use of numerical calculations.

RESULTS: The search identified 918 records, with 17 meeting the inclusion criteria, describing 16 methods. The methods varied in their reliance on numerical calculations and their degree of objectivity, with a significant correlation between both.

CONCLUSION: Our findings indicate that quantitative methods involve subjective decisions, particularly in endpoint identification and relevance assignment, which means they cannot eliminate the subjectivity and bias for which qualitative methods are criticized. The findings support previous observations of ambiguity in the regulatory process, amplified by technologies with hard-to-quantify risks, and suggest that current BRA methodologies are often limited and may be insufficient to guide developers and regulators.

PROTOCOL REGISTRATION: https://doi.org/10.17605/OSF.IO/RT4SV, identifier is osf.io/rt4sv.