Guidance

Leading practice guidelines

Published 17 December 2025

As outlined in the Government’s response to the 2021 consultation on the future regulation of medical devices, the MHRA intends to introduce specific requirements for devices manufactured and used under the Health Institution Exemption (HIE), aimed at promoting their safe and effective production. Until the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (MDR 2002) are updated, the MHRA considers that the leading practice guidelines outlined below will help enable the safe and effective manufacture of medical devices under the HIE.

The MHRA will not consider the use of the HIE for general medical devices an enforcement priority provided the specified conditions for use are met and the leading practise guidelines are followed.

Market Scanning

Before developing a device under the HIE, health institutions should assess whether commercial alternatives are available. Market scanning involves looking across the UK for devices that meet the same intended purpose, equivalent performance or target patient group.  

The MHRA advises that the HIE should only be applied when:

• No equivalent device on the market meets the specific needs of the target patient group, or
• Available alternatives do not meet the required performance level.

The health institution should duly justify in its documentation that the target patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market.

Health institutions should also conduct ongoing market surveillance after the device is put in use to monitor for emerging commercial options. The frequency of this activity should be proportionate to the type and risk profile of the device.

Device manufacture to an appropriate Quality Management System

Health institutions manufacturing devices under the HIE should operate within an appropriate Quality Management System (QMS) to ensure device safety, performance and effectiveness. A QMS provides a structured framework to minimise risks to patients and users, document decisions and actions and to support continuous improvement.

The minimum requirement is a standard suitable for the scope of devices covered. Essential elements include:

• Device selection and management
• Record keeping throughout the device lifecycle
• Design, manufacture, and performance review
• Monitoring use and reporting incidents

ISO 13485 is a Quality Management System standard for a medical device. The QMS may apply to the entire institution or only the relevant departments. Health institutions are encouraged to consider certification, which can strengthen regulatory confidence and internal quality assurance.

Meeting the relevant essential requirements of the MDR 2002

Health institutions should demonstrate that their device meets the relevant essential requirements in Part II of the UK MDR 2002, Annex I, as modified by Schedule 2A.

Not all requirements will apply to every device. Health institutions should:

• Identify applicable essential requirements
• Provide evidence of compliance, using designated standards where appropriate
• Justify exclusions, e.g., if a device doesn’t include biological materials, that requirement can be excluded with a clear rationale

The MHRA intends to update the essential requirements in a forthcoming Pre-Market Statutory Instrument and will publish further guidance on how to demonstrate conformance to the updated requirements.

Technical Documentation for HIE Devices

Health institutions manufacturing devices under the HIE should maintain comprehensive, clear and searchable technical documentation to demonstrate compliance with relevant essential requirements. This documentation should be sufficiently detailed to show how safety, performance, and quality standards are met. For example, if biocompatibility is relevant - such as for invasive devices - health institutions should compile and review existing data or test reports aligned with applicable standards to demonstrate safety.

For more details, see MHRA’s guidance on regulating medical devices in the UK.

Informed Patient Consent

Health institutions should ensure that patients are informed when a medical device has been manufactured under the HIE. This helps patients understand any associated risks and supports transparency in care. It is good practice to:

• Clearly communicate the nature of the device and its exemption status
• Provide relevant risk information in a format that is accessible and proportionate
• Obtain and document informed consent before use

For further guidance, refer to the Health Research Authority’s best practice on informing participants and seeking consent.

Maintain appropriate records

To maintain safety and effectiveness, health institutions should ensure traceability and oversight of devices manufactured under the HIE. This includes having clear record-keeping processes to identify devices and take corrective actions if needed (e.g. recalls or modifications).

A central record should be maintained of:

• Devices manufactured under the HIE
• Device users and locations
• Asset details in the organisation’s equipment inventory

Each health institution should determine how best to implement these processes within their own systems.

Public declaration

Health institutions should draw up a public declaration for their HIE devices. The declaration should contain the following:

• The name and address of the health institution
• The details necessary to identify the devices (e.g. product names, product code or reference, traceability information and description of the device)
• The intended purpose of the devices
• A declaration that the devices meet the essential requirements set out in in Part II of the UK MDR 2002, Annex I, as modified by Schedule 2A

The declaration should be made publicly available (e.g. on the relevant Health Institution’s website).

Adverse Incident Reporting and Post-Market Surveillance

To ensure ongoing patient safety, health institutions manufacturing or using devices under the HIE should implement a post-market surveillance (PMS) system. This includes maintaining a documented procedure to regularly review device performance and user experience.

If incidents arise, health institutions should take appropriate corrective or preventive actions, such as:

• Modifying the device or its use
• Reviewing past results
• Temporarily or permanently suspending use

All adverse incidents involving devices should be reported to the MHRA via the Yellow Card scheme. This helps identify safety concerns early and prevent harm. Further guidance and access to the Yellow Card reporting system is available at: Yellow Card Scheme.

Clinical investigation requirements

You must notify the MHRA before you carry out a clinical investigation of a medical device if it does not fall under the Health Institution Exemption as outlined in MHRA flowcharts. These flowcharts can be found on MHRA’s Clinical Investigation guidance.

To aid our development of future guidance and policy in this area, we are requesting that health institutions notify us when running a clinical investigation under the HIE. Notification can be sent via email to CI-applications@mhra.gov.uk and we request that notifications contain the following information:

• Details of the device and its manufacture
• Study Synopsis including aims and objectives
• Details for Chief Investigator or point of contact for the study

In instances where it is unclear if the health institution exemption applies to a study, the MHRA may advise on the application of the exemption.

Manufacturers conducting device studies under the HIE are encouraged to comply with Good Clinical Practice principles outlined in ISO 14155 (where applicable) in addition to the other documentation requirements outlined in this guidance.