Guidelines and regulations applicable to vitro diagnostic tests in the UK: a scoping review

Abstract

To describe recommendations applicable to new diagnostic and screening tests brought to market in the UK as of 01 June 2023; and extract agreements, disagreements and gaps.Extant regulations, recommendations and guidelines for new diagnostic and screening tests applicable to new products placed in the UK market as of 01 June 2023. Non-English and references not applicable to new tests seeking market access in the UK on 01 June 2023 were excluded.PubMed, Web of Science Core Collection and Scopus; grey literature via EuropePMC and Google, government regulations and guidelines, and relevant professional societies. References of relevant included data were scanned for includable articles. Resultant data were thematically analysed and presented as a narrative scoping review.PubMed, Web of Science Core Collection and Scopus were searched from 1/1/2018 for regulations, guidelines or recommendations for in vitro diagnositic tests as applied to the UK on 1/6/23. Relevant papers also had references searched.943 items were initially identified with 892 excluded. Reference searching located a further 31 papers and 82 items were analysed. Seven themes were identified: regulation, companion diagnostics and lab developed tests, safety and evidence, test specific recommendations, data, innovation and recommendations for patients/the public. Wide agreement included the need to reduce bureaucracy and duplication; to mitigate to avoid unintended consequences of In Vitro Diagnostic Regulation. Disagreement over whether high-quality evidence should precede regulatory approval, or could be gathered as part of postmarketing surveillance emerged.Industry, regulators, academics, patients representing a variety of views, should collaborate to work through areas of disagreement.