Recommendation 1

HM Government Accepted

. In the Government’s response to the IMMDS Review, published in July 2021, we accepted both recommendations 6 and 7 of the Review. Recommendation 6 covers the Medicines and Healthcare products Regulatory Agency’s (MHRA) role in relation to adverse event reporting and medical device regulation, as well as patient engagement. MHRA remains committed to delivering on this recommendation and has over the last two years delivered an ambitious organisation-wide transformation to ensure it becomes a progressive and responsive patient-focused regulator of medical products. It has established a new organisational structure to improve how it listens and responds to patients and the public and has developed a more responsive system for reporting adverse incidents, which will strengthen the evidence to support timely and robust decisions that protect patient safety. The MHRA’s Patient Involvement Strategy, published in October 2021, sets out how they will engage and involve the public and patients at every step of the regulatory journey. engagement and involvement, as well as embedding the public and patient voice when designing and delivering its services. With these objectives in mind since 2021, the MHRA: • Have been involving patients in the early stages of medicinal product development and encouraging the wider research landscape to do the same. • Are incorporating patient views and lived experience in more of our benefit-risk reviews of medical products. Government Response: Follow-up on the IMMDS report and the Government’s response 3 • Developed a more consistent and effective approach to public consultations by introducing an enhanced and user-friendly on-line platform. • Have launched a training programme on patient involvement, specially designed for our staff and built a network of staff “Patient Involvement Champions”. In addition, over 2,400 members of the public have given their views on a new scheme which will help the MHRA understand and reduce the number of harmful side effects caused by medicines. MHRA recognise there is more to do to ensure they deliver on their commitment to put patients first, and this is just the start of a journey. Recommendation 7 of the IMMDS Review calls for a central patient-identifiable database to be created by collecting key details of the implantation of all devices at the time of the operation, to be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures. Over 2021– 2022, NHS Digital undertook a scoping exercise to determine how best to deliver this recommendation. It was concluded that, for England, expanding the coverage and breadth of existing registries will best deliver harmonised data collections that contain patient, device and outcome-level data. NHS England have, since Summer 2022, commenced the developing of an ‘Outcome and Registries Programme’ as well as a new ‘Medical Device Outcome Registry’ (MDOR) and have been working to establish the programme at pace including governance, patient representation, clinical leadership, a technology platform and a coverage roadmap to deliver patient-centred change. The programme will involve a single unified outcome registry platform which will cover the priority medical specialties and therapeutical areas, prioritised according to patient and clinic risk. This aims to deliver on the priorities of traceability and patient outcomes through the enhancement of proven registry processes. NHSE are working through technical barriers and set to achieve the planned date for platform development in March 2023 with a view to then final testing of the platform and onboard process before launch in April 2023. NHSE is establishing clinical steering boards in the top 10 medical device specialties that account for over 80% of implant usage, to guide the development and implementation of registries and resolve emerging device safety issues. 6 specialty steering boards have been established, with 4 more in progress and a target to having all 10 operational by the end of March 2023 prior to launch of the MDOR platform in April 2023. The development work for the rapid expansion of the registries has been progressing. This has included the development of a new medical device-level registry platform architecture. NHSE is also in the process of transitioning several existing registries to the new platform. The pelvic floor registry is operational in NHS England and an improved version, integrated with the Outcome Registries platform is in pilot and due for release with the wider platform in May 2023. and involvement. There are three levels of patient involvement envisaged for the programme: existing patient involvement in outcome registries, the recruitment of patient 4 Government Response: Follow-up on the IMMDS report and the Government’s response representation onto the Outcome and Registries Programme Board) and the development of a Patient Adviso