Pushing your device through MHRA Regulation?

Achieving Classification

PsyMetRiC launched for clinical use in Great Britain in March 2026, one of the first psychiatric prediction tools to be registered as a Class 1 Medical Device with the MHRA.

The device focuses on serving young people at the onset of severe mental illness (SMI), such as psychosis, by predicting any comorbid physical health decline. The patient’s mental illness conditions are often not the cause of early mortality, 15-20 years on average, but instead the drivers are preventable contributors like heart disease and diabetes.

This tool joins the MHRA medical device cohort by solving a health equity issue. Specifically tailored for people who need acknowledgement, PsyMetRiC’s presence decreases the likelihood of a standard tool under-predicting an SMI patient’s risk.

The PsyMetRiC team have done what often seems unreachable to many aspiring developers. Supported by the University of Birmingham Enterprise and NIHR awards, PsyMetRiC has broken through the regulatory barrier and has begun changing the lives of young people.

Inside PsyMetRiC’s Success

CERSI-AI had the great pleasure of speaking with founding members of PsyMetRiC’s team. This allowed us exclusive access to a gold mine of invaluable advice from two successful professionals who empathise with MHRA processes.
• Dr Benjamin Perry: Founder of PsyMetRiC and Lead researcher and Associate Clinical Professor of Psychiatry at the University of Birmingham.
• Ben Hammond: Co-founder of PsyMetRiC and MB PhD student at the University of Birmingham
So, how did they do it?

The PsyMetRiC team have done what often seems unreachable to many aspiring developers. Supported by the University of Birmingham Enterprise and NIHR awards, PsyMetRiC has broken through the regulatory barrier and has begun changing the lives of young people.

The Barriers

Once registered with the MHRA, your tool has a responsibility to impeccably serve patients and healthcare professionals in clinical practice. No more theoretical. That device is out there making an impact on real people’s lives. It is no surprise that MHRA regulation is daunting and difficult. Problems arise even in the initial stages.

Dr Ben Perry revealed the origins of PsyMetRiC as “just an equation sat in a manuscript”, later recalling that “there’s something like 10,000 new prediction models published every year, and next to none of them get through into practice.”

Ben Hammond highlighted another problem, discussing the lack of training that some academic and clinical teams have: “You’re not trained how to be in quality assurance, you’re not trained how to be in regulatory compliance, but all of a sudden, if you go to the MHRA, you’re going to have to be your quality assurance manager.”

Expert Guidance: Advice from the Professionals

We asked the team to reflect on their experience navigating the tightly woven fabric of MHRA standards and regulations. Dr Ben Perry and Ben Hammond both gave advice for innovators determined for success.

• Post-Publication Plan
  “I think there’s often a naivety to everything that comes afterwards.” Ben Hammond warns against innovators being halted post-publication due to a lack of knowledge about what comes next. Get to grips with the regulatory requirements, safety standards, and responsible innovation steps required to make a tool clinic ready.
• Focus on the “End-Point”
  Ben Hammond also emphasises the importance of detaching oneself from the “publication cycle” that academia rewards. He suggests considering clinical implementation and MHRA viability from the very beginning. This is an effective mindset for getting tools into use, rather than adding to the pool of published models that never reach clinical spaces.
• Stakeholder Collaboration
  A key aspect of a tool’s success is stakeholders, so engage them early. This ensures that your device addresses desirable outcomes that are meaningful to all parties: “people with lived experience, the end users, potential customers”. Dr Ben Perry believes that this collaboration “smooth[s] that path towards translation.”
• Build internally
  Dr Ben Perry suggests the necessity of upskilling your internal team. He argues that the more a team knows, the less reliant they need to be on external companies that absorb precious funding. This expertise also ensures long-term sustainability and evolution that doesn’t rely on constant grants.
• Embrace the Challenge
  “Nothing that is worthwhile is easy,” a sentence that perfectly encapsulates the MHRA process. Dr Ben Perry describes his experience with tricky regulatory pathways, but notes that the end result is safer and more trustworthy. He encourages innovators to push through these rigorous steps to emerge on the other side with their work making real impact.

Ready for the Challenge?

Following this advice will allow your tool to move beyond the sea of research and be trusted by clinicians and patients for real healthcare decisions. While an arduous road, the impact of an official certification cannot be understated.

PsyMetRiC has already been used in over 4,000 clinical risk consultations since its launch, fulfilling the promises made across the tool’s development.

Thank you to Dr Ben Perry and Ben Hammond for taking the time to discuss their project and reflect on their experience to guide peers and innovators.