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Patients across England, Wales and Scotland could benefit from updated guidance on the Health Institution Exemption published today (17 December) by the Medicines and Healthcare products Regulatory Agency (MHRA).

This will support hospitals and other health institutions to manufacture new devices, or modify existing devices, to meet specific clinical needs for their own patients – from specialist software that supports precise drug dosing to communication aids designed to help patients with a communication impairment.

The updated leading practice guidelines will provide health institutions clearer direction on when and how the Health Institution Exemption can be applied in practice. This aligns with the UK government’s missions, including the 10 Year Health Plan for England and the Life Sciences Sector Plan, and their focus on the role of technology in health services.

The update follows a recent survey of health institutions and sets out five core principles that they should follow: maintaining quality management systems, ensuring device traceability, meeting the essential requirements, keeping technical documentation, and ongoing monitoring of how devices perform. The guidance also includes practical, everyday scenarios to help medical physicists, clinical engineers and other healthcare professionals understand when the Health Institution Exemption applies. 

The guidance also provides examples to clarify the types of organisations that may fall within scope, and those that do not, such as gyms, spas and fitness centres. It explains expectations where manufacturing activities are carried out on behalf of a health institution by a third party, and simplifies the use of key terms to reduce the risk of misunderstanding and ensure consistent application.  

Health institutions are encouraged to check whether suitable products are already available before developing their own. Where they do create a device, they should follow appropriate quality processes, keep clear records, and inform patients when a device has been made under the exemption. The updated guidance applies to general medical devices only and does not extend to in vitro diagnostic devices (IVDs). Importantly, any safety concerns should be reported through the MHRA Yellow Card scheme. 

Notes to editors  

1. The full guidance can be accessed here: Health Institution Exemption for general medical devices – GOV.UK. This guidance replaces the previous guidance on in-house manufacture of medical devices in Great Britain. The Health Institution Exemption only applies when devices stay within the health institution that made them. Custom-made devices – such as custom wheelchairs or prosthetic appliances – must follow separate custom-made device regulations. Health institutions in Northern Ireland should refer to separate EU-aligned guidance. 

2. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.  

3. The MHRA is an executive agency of the Department of Health and Social Care.  

4. For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

Paul and Peter were chosen because their work embodies Queen Mary’s aims, ambitions and values, and because they both mirror the University’s 240-year ethos of inclusivity and opening the doors of opportunity to anyone with the potential to succeed.

Paul Stephen, Awarded a Fellowship

Paul Stephen was Principal and Chief Executive of Newham College of Further Education, London’s top-performing further education college, from 2017 to 2025. In that time, Paul worked closely with Queen Mary on a number of successful projects, including securing £28million in funding from the Department for Education and Greater London Authority to establish the London City Institute of Technology.

Paul also supported the development of Queen Mary’s Civic University Agreement and was a valued member of the University’s Civic Advisory Board. In this role, Paul gave support and guidance to help Queen Mary determine area of focus that will ensure the University delivers positive, impactful change across East London.

On receiving his fellowship, Paul said: “I am delighted to accept the award of Fellowship from Queen Mary University of London. Throughout my career I have helped to form successful partnerships between distinctive organisations, and the relationship with Queen Mary is one of which I am truly proud. 

“In Queen Mary, I found a values-driven organisation whose staff showed vision, curiosity and ambition to create a powerful alliance that is already improving the educational experience and opportunities for the local communities we serve.”

Dr Peter Waggett, Awarded an Honorary Doctor of Sciences (DSc)

An alumnus of Queen Mary, Dr Peter Waggett graduated from the University with an undergraduate degree in astrophysics. After this, he completed a PhD in astronomy, after which he moved to the commercial sector, joining a scientific consultancy, which was subsequently acquired by IBM. Dr Waggett is now the Research Director at IBM, running their UK research programme. 

Committed to giving back, Dr Waggett actively works with Queen Mary colleagues to find ways to support his Alma Mater. Whether it’s connecting staff and students with opportunities at IBM, or helping secure grants that open the doors for technology experts to engage with quantum computing on a global scale, Dr Waggett works to ensure that new generations of students are given the same transformative opportunities that he benefited from himself, during his time at Queen Mary.

Speaking on receiving his award, Dr Waggett said: “As the first person in my family to attend University, the opportunities and support from Queen Mary during my BSc course gave me all I needed to follow a research career path.  

“My success in academic and industrial research roles would not have been possible without attending Queen Mary and I am honoured to accept this award for myself, and as a representative of those students that Queen Mary has opened research career paths for.”

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