Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies.

Abstract

A positive benefit-risk profile is a prerequisite for the market approval of medical devices. However, regulations are often criticized for providing limited information on benefit-risk assessment (BRA) despite growing expectations for quantitative methods. A clearer understanding of regulatory requirements, existing methodologies, and unresolved issues is needed. Relevant regulatory documents referencing BRA for medical devices were systematically identified, with a primary focus on the Europea