PubMed

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

PMID: 42400285 · 2026-07-30

E, l, e, n, a, , S, c, h, e, l, l, e, r, ;, , J, u, l, i, a, , R, o, h, r, b, e, r, g, ;, , M, i, c, h, a, e, l, , D, ', A, g, o, s, t, o, ;, , M, a, t, t, h, i, a, s, , K, o, h, l

学術誌Expert review of medical devices

年2026-07-30

PMID42400285

抄録

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

公式ソース

PubMedで見る →

データはPubMed / NCBIから取得しています。全文および最新情報は必ず公式記録をご確認ください。