PubMed

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

PMID：42400285 · 2026-07-30

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期刊Expert review of medical devices

年份2026-07-30

PMID42400285

摘要

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

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