Browse by author
Lookup NU author(s): Tim HicksORCiD, Joe Bulmer, Dr Alison Bray, Dr Jordan OakleyORCiD, Dr Rachel BinksORCiD, Dr Kile GreenORCiD, Dr Will Jones, Professor James WasonORCiD, Professor Kevin WilsonORCiD
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
© Author(s) (or their employer(s)) 2026. No commercial re-use. See rights and permissions. Published by BMJ Group. Background: This review of legislation, official policy guidance and standards across the UK, the European Union (EU) and USA aimed to identify regulatory requirements relating to statistical methodology for diagnostics development outlining barriers and opportunities for novel study designs. Methods: The search was conducted between February 2024 and April 2024 for legislation, official policy guidance and standards across the UK, EU and USA. Search terms included: Medical Device, In Vitro Diagnostic, Medical Diagnostic, Diagnostic and IVD. Documents were screened by title, with a subset of documents being double screened. Included documents underwent a search for 25 statistical key terms and statistical requirements were extracted. Eligibility criteria: documents were included if they related to medical diagnostic device development. Documents which related to risk management, postmarket surveillance and quality assurance, while important, were beyond the scope of this review and were excluded. Data sources: EUR-Lex, WestLaw UK, US Food and Drug Administration, Lexis+, Policy Commons, Medical Device Co-ordination Group and the British Standards Online Library. Results: 404 documents (total=2479) met the inclusion criteria for data extraction. 128 (32%) had statistical requirements for medical diagnostic development. Of the 1146 requirements identified, 275 were mandatory for specific high-risk tests or conditions (UK only=4, EU only=170, EU/UK=74, USA=27). Recommendations for best practice covered: evidence requirements, statistical validity, study design and management. Discussion: Mandatory statistical requirements exist for high-risk areas, limiting novel study designs; however, there remains opportunity to improve efficiency in the diagnostic development pathway for low risk diagnostics.
Author(s): Hicks T, Bulmer J, Bray A, Oakley JL, Binks RL, Green K, Jones WS, Wason JMS, Wilson KJ
Publication type: Review
Publication status: Published
Journal: BMJ Innovations
Year: 2026
Pages: Epub ahead of print
Online publication date: 16/06/2026
Acceptance date: 05/05/2026
ISSN (print): 2055-8074
ISSN (electronic): 2055-642X
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bmjinnov-2025-001439
DOI: 10.1136/bmjinnov-2025-001439
