The MHRA launches the development of its new five-year strategy - can we predict their next steps?
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is developing a new strategy to provide its direction, mission, values and focus through to 2030. What should we expect?
What will be the MHRA's focus over the next five years?
Adapting to new technologies and advances
Innovation is very much a key area for the government and features heavily in its recently published Life Sciences Sector plan. The MHRA has repeatedly acknowledged that it needs to consider and adapt its regulatory approach to cater for new, rapidly growing areas, including cell and gene therapies for personalised medicine and AI as a medical device - and in its blog post announcing the development of its new strategy, it has stressed that new technological and scientific advances will be a focus over the next years.
Considering innovation more broadly, the MHRA will be busy delivering changes connected to the third pillar of the government's recently published 10-year Life Sciences Sector plan: Driving Health Innovation and NHS Reform - ensuring patients get rapid access to the most clinically and cost-effective new technologies, and enabling the shifts from sickness to prevention, hospital to community, and analogue to digital. The government has stated that this will be implemented through various measures including:
- Increasing MHRA efficiency through use of AI and other technologies.
- Capitalising on the MHRA's thought leadership and reputation in AI and Software as a Medical Device to be the fastest, safest, and quickest place to regulate AI and Software.
- The development of a route for international reliance for medicines and medical devices.
- Speeding up clinical trial set-up and delivery.
So, what are the next steps? As well as digital adoption and widespread domestic regulatory reform to streamline processes and support innovation (see below), both of which are currently ongoing, the plans of course require regulatory cooperation and harmony at international level. In its response to its consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, the government has confirmed that it plans to move forward with an international reliance system for products approved by four comparable regulator territories: Australia, Canada, the EU and the USA, subject to certain conditions. This is intended to reduce the regulatory burden and allow both regulatory and manufacturer resources to be focused on new technologies, with the aim of improving patient access to new devices. As part of wider amendments to 'pre-market' requirements currently being undertaken (see below), we can expect to see legislative amendments relating to international reliance later this year.
Continuing with reforms for medical devices and IVDs
The MHRA is already busy with reforms to medical devices. At the start of the year, we discussed the revised roadmap published by the MHRA which sets out its new timeline for implementing reforms to the UK's medical devices regulatory framework. The next major step is the introduction of new 'pre-market' requirements. Before being introduced to parliament, the new regulations are required to be published on the World Trade Organisation's website - which is expected to take place later this year.
From the MHRA's response to its consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, we have an understanding of legislative changes that can be expected. As well as amendments focused on international reliance, the MHRA has confirmed that the legislation will require the assignment of a Unique Device Identification (UDI) to medical devices prior to making them available on the UK market. The UDI will be similar to a barcode and is intended to improve transparency and oversight by allowing a specific medical device and its manufacturer, or the person who made the device available on the market, to be easily identified by looking at a device.
The MHRA is also looking at in vitro diagnostics (IVDs) in its reforms. In the new legislation for 'pre-market' requirements, the MHRA plans to introduce amended conformity assessment routes for IVD devices to create a more risk proportionate system. The aim is to reduce regulatory burdens for low-risk devices and also ensure that risk levels more accurately reflect health challenges, both now and in the future. Reforms to IVDs are essential to support the government's Life Sciences Sector Plan. As IVDs can assist with accessible and personalised disease detection, diagnosis and management, supporting their innovation and development is crucial to transforming healthcare through Driving Health Innovation and NHS Reform, and will undoubtedly be a key area for the MHRA in the next few years.
Focusing on patient access and needs
The MHRA is keen to emphasise in its blog post that supporting novel therapies is important to best serve patients and support different healthcare preferences, and states that it is working to define a clearer framework for risk-proportionate regulation. While the MHRA is certainly embracing innovation and preparing to adapt regulation to speed up access to new devices and therapies, we should expect the MHRA to proceed with an element of caution over the next few years and for its guidance to balance patients' preferences alongside safety and efficiency.
What's going on in Europe?
In its blog post, the MHRA also expressed a desire to listen and learn from partners, with a strategy built on engagement. As well as listening to industry, we can expect the MHRA to also keep an eye on how other regulators approach major reform and adapt to technological advances. In December 2024, the European Commission launched a consultation and call for evidence in relation to EU regulations 2017/745 and 2017/746 on medical devices and IVDs. The consultation received 584 responses, many of which cited issues with interpretation and transparency, as well as stressing that the regulations were blocking researching and innovation. Following the closure of the consultation in March, the Commission is now analysing the inputs and preparing its findings, with adoption currently planned for the fourth quarter of this year. The MHRA did, however, acknowledge the scale of what the EU attempted with the 2017 regulations and reiterated that it is taking a more stepped approach. Therefore, as mentioned above, though there are big plans for reform and transforming healthcare in the UK, the MHRA is mindful of doing too much too soon - and so, we should expect the staged and consultation-led approach to continue.
What should your business be doing?
This year has already seen significant regulatory change. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force on 16 June, amending the Medical Devices Regulations 2002. Under the new regulations, manufacturers must have a Post-Market Surveillance (PMS) system, based on a PMS plan. Changes in relation to investigation, reporting and preventative and corrective action requirements were also brought in. As well as ensuring that they are on top of these changes, manufacturers should review their agreements with distributors to make sure they contain appropriate provisions to enable compliance with their reporting obligations.
During this period of major regulatory change in both the UK and Europe, it is important to be aware of regulatory updates and take early preparatory steps. The MHRA has indicated that it will be publishing a series of blogs as it develops its new strategy. We will continue to comment on updates as they come, so keep an eye out on our website and let us know if you would like to receive our sector updates (if you do not yet receive them). Please also reach out to our team if you need any support understanding what the changes mean for you.
The 2026 PING Conference will look at Britain's place in the global pharma world 10 years on from the Brexit vote and we will be exploring regulatory change as part of this. Further details will be coming over the next few months, so please check our website for updates.