Leading regulatory innovation that drives international harmonisation We will build on wider work examining health inequalities in medical device regulation, ensuring specific work on SaMD and AIaMD builds on that foundation, focusing on specific issues that AIaMD can pose over and above medical devices. The MHRA recognises that SaMD and AIaMD must perform across all populations within the intended use of the device and serve the needs of diverse communities. Building on the existing MHRA Patient and the Public Engagement Strategy, we will engage patients, public, and the wider sector (including healthcare and industry) throughout this change programme and most of these deliverables will be released first as drafts for wider comment and input before being published. The new regulatory framework must also be pragmatic and attract responsible innovation to the UK. We recognise that the use of AIaMD raises broader societal questions and that the public voice needs to be heard in establishing how the MHRA regulates these devices to ensure safety. We will also announce plans for patient/public and industry engagement to support this work programme. Much of the work below will continue to be developed in collaboration with partner organisations in the Multi Agency Advisory Service, namely NICE, Care Quality Commission (CQC), and Health Research Authority (HRA). This programme of work has been developed with support and input across government and the NHS as well as with targeted engagement with devolved administrations, trade associations, academia, and industry partners. Much of the programme builds upon legislation through guidance, for instance, by clarifying what medical device requirements mean in the context of software and AI. Some (but not the majority) of the changes intended will be in the form of secondary legislation, these have been consulted upon as a part of a consultation on the future regulation of medical devices in the United Kingdom. The first stream contains eight work packages to make key reforms across the software as a medical device (SaMD) lifecycle, the second stream has three work packages and considers the challenges that AI as a medical device (AIaMD) can pose over and above classically programmed software. This programme includes eleven work packages across two workstreams. Internationally, we will work with other regulators both bilaterally, and multilaterally through the International Medical Device Regulators Forum (IMDRF) to strengthen international convergence and consensus on software and AI products. Broadly, to achieve this aim, we will focus on ensuring that:Ī.The requirements for software and AI as a medical device provide assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public.ī.The requirements for manufacturers are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards.Ĭ.The friction is taken out of the market by working with key partners such as the National Institute for Health and Care Excellence (NICE) and NHS England to align domestically, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK. The Change Programme will deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and public, but also makes sure that the UK is recognised globally as a home of responsible innovation for medical device software looking towards a global market. Set out below is further information on each work package of the Change Programme, including deliverables to meet each set of broad objectives, and further information on how the broad Change Programme will be implemented. This Programme builds upon wider reforms for medical devices as a whole detailed in the Government response to consultation on the future regulation of medical devices in the United Kingdom. Last year, the MHRA announced the Software and AI as a Medical Device Change Programme, a programme of work to ensure regulatory requirements for software and AI are clear and patients are protected. In the UK, many of these products are regulated as medical devices. Software (including Artificial Intelligence (AI)) plays an essential part in health and social care.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |