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August 15, 2025
Approximately 5 minutes
Health Institution Exemption for General Medical Devices in the UK
Health Institution Exemption for General Medical Devices in the UK
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Overview and Scope The Health Institution Exemption (HIE) is a provision under the UK Medical Devices Regulations 2002 (UK MDR 2002) that allows health institutions to manufacture, modify, and use medical devices on a non-industrial scale within the same legal entity. Devices produced under this exemption do not require a UKCA mark but must still meet high standards of safety and performance. Source: Health institution exemption (HIE) for general medical devices
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Requirements for Health Institutions To benefit from the HIE, a health institution must comply with specific conditions:
The device must not be transferred to another legal entity.
The device must be manufactured and used under an appropriate quality management system.
The institution must justify why the target patient group's needs cannot be met by an equivalent CE or UKCA marked device available on the market.
Information on the manufacture and use of these devices must be made available to the MHRA upon request. Source: Health institution exemption (HIE) for general medical devices
- Documentation and Safety Health institutions must draw up documentation that allows an understanding of the manufacturing facility, the manufacturing process, the design, and performance data of the devices. This documentation must include:
A declaration that the devices meet the relevant Essential Requirements.
A review of clinical experience gained from the use of the devices.
Records of the manufacturing process to ensure consistent quality. Source: Health institution exemption (HIE) for general medical devices
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Reporting Adverse Incidents Even though these devices are exempt from UKCA marking, health institutions are still required to report any serious adverse incidents involving devices made under the HIE to the MHRA via the Yellow Card scheme. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
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Industrial Scale and Commercialization The exemption specifically excludes devices manufactured on an "industrial scale." If a health institution intends to supply the device to other hospitals outside its legal entity or commercialize the product, it must comply with the full requirements of the UK MDR 2002, including conformity assessment by an Approved Body and affixing a UKCA mark. Source: Medical devices: conformity assessment and the UKCA mark
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