Key Summary
- The new guidance will support hospitals and other health institutions, and does not cover gyms, spas and fitness centres
- These institutions can manufacture new devices, or modify existing ones, to meet specific clinical needs for their patients
- The guidelines will provide clear instructions on when and how the Health Institution Exemption can be applied in practice
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated guidance on the Health Institution Exemption, which will support hospitals and other health institutions to manufacture new devices or modify existing ones to meet specific clinical needs for their patients.
The new guidance applies only to general medical devices and does not extend to in-vitro diagnostic devices, nor does it cover institutions such as gyms, spas, and fitness centres.
The update follows a recent survey of health institutions, and it 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.
The updated guidelines will also provide health institutions with clearer direction on when and how the Health Institution Exemption can be applied in practice.
The update sets out five core principles that the institutions need to 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.
There are separate rules for manufacturing activities that are carried out on behalf of a health institution by a third party.
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.
Importantly, any safety concerns should be reported through the MHRA Yellow Card scheme.
