英国药品与健康产品管理局2022年1月至2025年12月收到的医疗器械临床研究首次申报分析

AIMS: This study aimed to analyse clinical investigation-device initial submissions received by the MHRA between January 2022 and December 2025.

METHODS: Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end-point was submission type. Secondary end-points were sponsor type, participant demographics, healthy volunteers, health categories and studies involving first-in-human. The analysis used descriptive statistics for all categorical variables.

RESULTS: The MHRA received 322 valid submissions; 60.3% were United Kingdom only, and the remainder were also conducted in 39 countries. Multi-country 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-market studies were the least common (0.3%). Commercial investigations accounted for 67.4%. Non-commercial 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-in-human 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%).

CONCLUSIONS: 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.