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The UK Medical Device Regulations landscape is going through a period of regulatory reform. To keep us informed of changes, Hardian Health, one of our delivery partners on the Mindset-XR Innovation Support Programme, discuss developments expected in the near future.

Launch of new Regulatory Innovation Office

In October 2024, the UK government announced the launch of the new Regulatory Innovation Office (RIO).

The office was set up to try to speed up access to new technologies by looking for ways to reduce the time taken for regulatory compliance processes. A key focus is innovative medical technologies and artificial intelligence (AI) in healthcare.  

As the current UK Medical Device Regulations (UK MDR) were originally created in the 1990s, one area this new office aims to support is in updating these regulations and improving the efficiency and speed of approvals.  

Many recent advances in healthcare innovation, including XR and VR tools for mental health, are not well described by current regulatory frameworks. This can pose challenges for innovators and manufacturers of such technologies when attempting to understand and apply the appropriate regulations.  

The creation of this office appears to align well with the current government’s pro-innovation approach to AI regulation and ambitions to make the UK a hub for the development of innovative technologies, as described in the AI Opportunities Action Plan. 

Notably, the RIO is not limited to healthcare. The mission of the RIO is to support four key innovative sectors including the UK space industry, autonomous technologies and vehicles like delivery drones, biotechnology and most relevantly to the Mindset-XR Programme, the use of AI and digital technologies in healthcare.  

In the healthcare sector, the office aims to support the NHS and UK healthcare to utilise AI and digital technologies to improve efficiency and patient outcomes. A chair of the RIO will soon be appointed to lead and progress these aims.  

Proposed changes to regulations

While the set-up of the RIO is underway, updates to the regulatory landscape for medical devices in the UK have been progressing.  

In fact, proposed changes to the UK MDR 2002 have already been announced by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicines and medical devices regulatory authority.  

Most recently, amendments were made to incorporate new, strengthened and risk-proportionate post-market surveillance requirements for medical devices on the UK market.  

These updates will come into force on the 16 June 2025 and include introduction of a mandatory requirement for a post-market surveillance plan, as well as improved data collection and more stringent timelines for incident and summary reporting (among other requirements). 

Over the winter, the MHRA also held a public consultation on the proposed changes to regulatory frameworks for medical devices on the Great Britain market, including increasing the classification of certain Software as a Medical Device (SaMD) and routes for international recognition.  

The results of this consultation will be used to inform planned regulatory framework updates.  

The UK Medical Device Regulations landscape is going through a period of regulatory reform, with increasing pressure to keep up with the rapid pace of technological innovation, particularly in the healthcare sector.  

On 3 February 2025, the MHRA published pivotal new guidance on the regulation and evaluation of Digital Mental Health Technologies (DMHTs).  

This guidance is the culmination of a unique collaborative project between the MRHA, NICE and the Wellcome Trust and provides the DMHT sector with a clarity on the interpretation of the regulations for mental health tech.  

The guidance document and extensive examples are a must-read for innovators aiming to access the UK market.  

Ultimately, the purpose of medical device regulations is to protect patients and the public while facilitating UK market access to innovative and responsibly-developed technologies.  

Moving forward

Any manufacturers or developers working in the healthcare space, such as those involved in the Mindset XR programme, should keep abreast of developments in the space as there are more changes on the horizon. 

As part of the innovation support offering, we at Hardian Health have worked with the HIN South London team to develop 10 bespoke Introduction to Regulation educational modules for the Mindset-XR programme cohorts. 

Programme participants are also encouraged to engage in the one-to-one consulting hours being offered by our team to support any project-specific regulatory questions.

To find out more, email hin.mindset@nhs.net