{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T09:03:13Z","timestamp":1790672593838,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:00:00Z","timestamp":1790208000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:00:00Z","timestamp":1790208000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>This study aimed to analyse clinical investigation\u2010device initial submissions received by the MHRA between January 2022 and December 2025.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end\u2010point was submission type. Secondary end\u2010points were sponsor type, participant demographics, healthy volunteers, health categories and studies involving first\u2010in\u2010human. The analysis used descriptive statistics for all categorical variables.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The MHRA received 322 valid submissions; 60.3% were United Kingdom only, and the remainder were also conducted in 39 countries. Multi\u2010country submissions included locations in Europe, North and South America, Asia and Australia. Submissions increased by 5% between 2024 and 2025. Pivotal studies were the most common (47.5%), while post\u2010market studies were the least common (0.3%). Commercial investigations accounted for 67.4%. Non\u2010commercial sponsors were highest in feasibility studies (56.2%); commercial in pivotal studies (54.4%). The population demographics across all studies involving both sexes were 91%, 6.5% female only, 2.5% male only and 5.6% pregnant women. Adolescents were the most represented paediatric group (10.6%), while in utero was rare (0.3%). Only one first\u2010in\u2010human study involved pregnant women. Across demographics, pivotal studies were highest in paediatric and in utero (51.1%). The three main health categories included in the submission were cardiovascular (16.5%), ophthalmology (10.9%) and respiratory (9.3%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Results highlight the UK clinical investigations landscape and provide an important baseline for patients, policymakers, healthcare providers, manufacturers and sponsors, enabling an assessment of how policy changes can increase the variety and number of clinical investigations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70830","type":"journal-article","created":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T12:46:07Z","timestamp":1790253967000},"source":"Crossref","is-referenced-by-count":0,"title":["Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3457-9981","authenticated-orcid":false,"given":"Andrea","family":"Manfrin","sequence":"first","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Grumbridge","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Hill","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Crina","family":"Cacou","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0211-563X","authenticated-orcid":false,"given":"Graham","family":"Warren","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Pound","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"George","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandro F.","family":"Frangi","sequence":"additional","affiliation":[{"name":"Centre for Computational Imaging and Modelling in Medicine (CIMIM), UK Centre of Excellence on in\u2010silico Regulatory Science and Innovation The University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010017\u20102329\u20109"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/17434440.2025.2508869"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-022-00463-4"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3619-6"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.17140\/CTPOJ\u20101\u2010102"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/app13137639"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462317000253"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.35840\/2633\u20108939\/7205"},{"key":"e_1_2_11_10_1","unstructured":"MHRA.The Medicines and Healthcare products Regulatory Agency (MHRA).2024. Accessed December 24 2024.https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency"},{"key":"e_1_2_11_11_1","volume-title":"The Medical Devices Regulations 2002","author":"UK Government","year":"2022"},{"key":"e_1_2_11_12_1","unstructured":"House of Commons Information Office.Statutory Instruments. Factsheet L7.2008. Accessed February 15 2026.https:\/\/www.parliament.uk\/globalassets\/documents\/commons-information-office\/l07.pdf"},{"key":"e_1_2_11_13_1","unstructured":"Medicines and Healthcare products Regulatory Agency (MHRA).Regulating medical devices in the UK.2025. Accessed February 15 2026.https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk#legislation-that-applies-in-great-britain"},{"key":"e_1_2_11_14_1","unstructured":"European Parliament and Council.Regulation (EU) 2017\/745 on medical devices. Amending Directive 2001\/83\/EC Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EE 2017.2017. Accessed February 15 2026.https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.5694\/MJA2.52059"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/bcp.70061"},{"key":"e_1_2_11_17_1","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2024"},{"key":"e_1_2_11_18_1","volume-title":"Medical devices clinical trials database","author":"GlobalData"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063\u2010025\u201008793\u2010y"},{"key":"e_1_2_11_20_1","unstructured":"World Health Organization.The top 10 causes of death. Accessed February 22 2026.https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/the-top-10-causes-of-death"},{"key":"e_1_2_11_21_1","unstructured":"Fortune Business Insights.UK medical devices market size share & industry analysis. Accessed February 22 2026.https:\/\/www.fortunebusinessinsights.com\/uk-medical-devices-market-114021"},{"key":"e_1_2_11_22_1","unstructured":"Medicines and Healthcare products Regulatory Agency (MHRA).UK medical device testing hits record high as MHRA backs growth in brain and AI technology. Accessed February 22 2026.https:\/\/www.gov.uk\/government\/news\/uk-medical-device-testing-hits-record-high-as-mhra-backs-growth-in-brain-and-ai-technology"},{"key":"e_1_2_11_23_1","unstructured":"Japeto AI.MHRA launches pilot fee waiver programme for small medical device innovators. 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