Abstract
Background
Gaps in regulation of diagnostic and screening tests have been highlighted in a series of well publicised safety incidents. The UK is preparing to update legislation by June 2025.
Objective
To describe recommendations applicable to new diagnostic and screening tests brought to market in the United Kingdom as of 01/06/23; and extract agreements, disagreements and gaps.
Eligibility Criteria
Extant regulations, recommendations and guidelines for new diagnostic and screening tests applicable to new products placed in the UK market as of 01/06/2023. Non English and references not applicable to new tests seeking market access in the UK on 01/06/2023 were excluded.
Sources of evidence
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 was thematically analysed and presented as a narrative scoping review.
Results
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 IVDR. Disagreement over whether high quality evidence should precede regulatory approval, or could be gathered as part of post marketing surveillance emerged.
Conclusions Industry, regulators, academics, patients representing a variety of views, should collaborate to work through areas of disagreement.
Gaps in regulation of diagnostic and screening tests have been highlighted in a series of well publicised safety incidents. The UK is preparing to update legislation by June 2025.
Objective
To describe recommendations applicable to new diagnostic and screening tests brought to market in the United Kingdom as of 01/06/23; and extract agreements, disagreements and gaps.
Eligibility Criteria
Extant regulations, recommendations and guidelines for new diagnostic and screening tests applicable to new products placed in the UK market as of 01/06/2023. Non English and references not applicable to new tests seeking market access in the UK on 01/06/2023 were excluded.
Sources of evidence
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 was thematically analysed and presented as a narrative scoping review.
Results
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 IVDR. Disagreement over whether high quality evidence should precede regulatory approval, or could be gathered as part of post marketing surveillance emerged.
Conclusions Industry, regulators, academics, patients representing a variety of views, should collaborate to work through areas of disagreement.
| Original language | English |
|---|---|
| Journal | BMJ Innovations |
| Volume | Online First |
| Early online date | 8 Aug 2024 |
| DOIs | |
| Publication status | E-pub ahead of print - 8 Aug 2024 |
Keywords
- Diagnosis
- Early diagnosis
- Evidence-based practice
- Genetics - medical, policy