A new and ambitious Delivery Plan centred on putting patients first, has been published by UK Regulator MHRA

The MHRA?has published a new delivery plan which aims to facilitate the UK life sciences sector and health service to quickly realise the benefits of new therapies and innovative technologies such as AI.

The regulator is set to design, consult and implement a?new legislative framework for medical devices, which will “support ongoing access to products with the aim of providing an environment in which to support safe innovation”, and encourage developers to bring products to the UK market.?The consultation is expected to be published by the end of Q2, 2021/22, with relevant statutory instruments laid by Q1, 2022/23.

Key priorities of the plan:

• The first priority is delivering better patient and public involvement. This includes making patient safety, engagement and transparency more prominent in the development of the new medical devices framework and implementing recommendations from the IMMDS Review.
• Scientific innovation, including a laboratory strategy and long-term plan to be published by the end of this year.
• Strengthening of international regulatory relationships and enhancing partnerships with the wider health system now that the UK has left the EU.
• Overhauling the clinical trials system. This will include a consultation on options for changing UK legislation to make conduct of trials generating real-world data easier and finalise and promote the Innovative Licensing and Access Pathway Novel Trial Design Tool by Q2, 2022/23.
• Further priorities include patient safety and risk management, a secure supply chain, delivering the regulator’s Transformation Programme to drive change and leveraging international partnerships.

The 14 objectives set out in the plan can be grouped into 6 central themes:

• Scientific innovation
• Healthcare access
• Patient safety
• Dynamic organisation
• Collaborative partnerships
• Financial sustainability