Advising on UK medical device regulation can currently be frustrating due to the uncertainties surrounding the regulatory regime. While the EU get used to the new Regulations, it remains to be seen what sort of regulatory landscape the UK will paint, the scale of the canvas, the level of detail, and the extent to which it complements other styles.
Perhaps in order to address some of this uncertainty, the Medicines and Healthcare products Regulatory Agency (MHRA), the body responsible for overseeing the regulation of medical devices and IVDs in the UK, has published a ‘Delivery Plan’ for 2021-2023 (https://www.gov.uk/government/publications/the-medicines-and-healthcare-...). At a crucial juncture in the MHRA’s evolution, the new Plan sets out an ambitious roadmap, intended to enable the Agency to achieve its goal of ‘putting patients first, becoming a truly world-leading, enabling regulator and protecting public health through excellence in regulation and science’.
Some of the notable commitments in the Plan may be summarised as follows:
The lessons of COVID-19
The Plan pays tribute to the agility demonstrated by the MHRA in facilitating and approving products to meet the demands of the pandemic while maintaining high standards of safety, efficacy and quality. Notwithstanding the extraordinary challenges of the pandemic, the Plan observes that the experience ‘…has also revealed what sort of organisation we can be’, presumably anticipating that regulatory agility will remain a feature of the MHRA’s approach going forwards.
The Plan highlights the opportunity to make the UK an attractive market for the development, manufacture and supply of products post-Brexit. It identifies the passing of the new Medicines and Medical Devices Act 2021 as the vehicle for regulatory evolution, committing the MHRA to ‘evolving and strengthening our regulatory framework so that it looks to the future and keeps pace with fast-moving life science developments’.
The 2021 Act does not implement any changes in itself but it creates regulation-making power which the Plan envisages will be utilised in the not too distant future. A public consultation on a new legislative framework for devices in the UK will be published by the end of Q2, 2021/22 and a response by the end of Q4 2021/22. Draft legislation will then follow by the end of Q1, 2022/23.
Surveillance and risk management
The Plan promises a more responsive medical device safety surveillance system which ‘…detects and responds to signals of issues more quickly and enables greater interaction with reporters’. This will commence with a review in 2021/22, with an agreed policy for a significantly enhanced transparency regime for device regulation by Q4, 2021/22 with key elements being delivered over 2022/23.
The MHRA has long been held in high regard by other international regulators, and it played a key role in the development and implementation of EU medical device regulation and oversight. Brexit necessitates a change in the MHRA’s role on the international stage, but the Plan emphasises the Agency’s commitment to maintaining and establishing new international regulatory relationships now that we are no longer part of the European regulatory framework. Of course, it remains to be seen whether the MHRA’s enthusiasm for international collaboration is shared by other jurisdictions, but the commitment is to be commended.