MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

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.