UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
Clinical investigations for medical devices are regulat- ed by the UK Medical Devices Regulations. Require- ments relating to clinical investigations under the EU MDR and the EU IVDR apply in Northern Ireland. The MHRA has stated that amended regulations for medical devices, when introduced by the UK govern- ment, will bring the essential requirements for medical devices being placed on the market in Great Britain into greater alignment with those of the EU, and it is therefore likely that the requirements for clinical inves- tigations will be revised at that stage. 2.2 Securing Authorisation to Undertake a Clinical Trial Before a clinical trial for a medicinal product may com- mence, a favourable REC opinion and an authorisation from the MHRA are required. The sponsor of a clinical trial must be established in the UK or in a country on an approved country list, which currently includes EU/ EEA countries. Alternatively, the sponsor must appoint a legal representative in the UK. As of 1 January 2022, applications for all new clinical trials for investigational medicinal products must be prepared, submitted through the Integrated Research Application System (IRAS) and reviewed via the com- bined review service – a single application route, which involves co-ordinated review by the MHRA and the REC, leading to a single UK decision. While this single application route is currently available in the UK through various schemes and pilots, it will be enshrined into law as the standard route for submis - sions when the Medicines for Human Use (Clinical Tri- als) (Amendment) Regulations 2024 come into force. After receipt of a valid application, an assessment will be conducted within 30 days. Following assessment, and ordinarily within 60 days of the submission, the MHRA and the REC will either: • accept the request; • accept the request subject to conditions; or • not accept the request. The MHRA considers the safety and scientific value of the trial, while the REC focuses on the research proposals, including the trial protocol; the informed
consent form; the suitability of the personnel, inves- tigator and facilities; and the investigator’s brochure. The MHRA must be notified by the sponsor at least 60 days in advance of the commencement of a clinical investigation involving medical devices. Applications should be submitted via the IRAS. The MHRA will con- sider the documentation and assess the safety and performance of the device, as well as the design of the investigation. A letter will be sent to the sponsor within 60 days with a decision (providing either an “objection” or “no objection”). In addition, an opinion of the REC is required. 2.3 Public Availability of the Conduct of a Clinical Trial A favourable opinion by a REC is conditional upon the clinical trial being registered on a publicly accessible database. Since 1 January 2022, the Health Research Authority (HRA) has automatically registered clinical trials sub- mitted through IRAS with the International Standard Randomised Controlled Trial Number (ISRCTN) reg- istry. Information about trials (for both medicinal products and devices) being conducted in the UK is made publicly available on the Health Research Authority research summaries website and on the UK “Be Part of Research” website. In addition, the Association of the British Pharmaceu- tical Industry (ABPI) Code of Practice requires com- panies to disclose details of clinical trials of medicinal products in accordance with international require- ments. There is currently no equivalent requirement in industry codes applicable to manufacturers of medical devices. 2.4 Use of Online Tools to Support Clinical Trials There are no restrictions on using online tools to sup- port clinical trials or clinical investigations. However, all advertising, recruitment and other materials pro- vided or directed to subjects must be reviewed and approved by the REC.
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