Guidance

General information on the Health Institution Exemption

Published 17 December 2025

In Great Britain, medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (MDR 2002). The MDR 2002 set out the requirements that manufacturers must meet to place a device on the Great Britain market or put it into service.

In vitro diagnostic (IVD) devices

Regulation 33 of the MDR 2002 exempts health institutions from certain regulatory requirements, provided specific conditions are met. This exemption - referred to in this guidance as the health institution exemption - applies to health institutions that manufacture in vitro diagnostic (IVD) devices and their accessories, where the following conditions are satisfied:

Condition 1: The IVD devices are used within the same premises of the health institution that manufactured them, or in the immediate vicinity; and

Condition 2: The IVD devices are not transferred to another legal entity.

General medical devices (including software and implantable devices)

The MDR 2002 do not currently include an exemption for general medical devices (including software or implantable medical devices). However, previous MHRA guidance has permitted the use of the HIE for these devices, and the MHRA recognises this as a long-standing practice in health institutions. The MHRA intends to formally introduce regulations for an exemption in the future, however health institutions should follow this guidance and consider the HIE applicable to all medical devices and accessories - provided the above conditions for use are met and leading practice guidelines are followed.

The MHRA emphasises the importance of clear terminology. In previous guidance, the term ‘in-house manufacturing’ or ‘in-house’ has been used, but the MHRA does not recommend using this moving forward to avoid ambiguity. It is important to note that not all devices made within a health institution will automatically fall within the scope of the exemption. An assessment should be made on whether the device is a custom-made device, whether the HIE applies, or whether full regulatory assessment is required. This guidance provides a range of scenarios to support health institutions in determining whether the HIE should be applied.

Definition of a health institution

A health institution is a body whose primary purpose is the care of patients and/or promotion of public health. Examples of bodies that qualify as health institutions are NHS Trusts/Boards, private hospitals and bodies, a dentist or GP practice, as well as UK government organisations whose primary purpose is to support care and treatment of patients and/or promote public health.

The MHRA considers that entities or establishments that are primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres, would not generally be defined as health institutions.

It is the responsibility of the entity to consider their primary purpose and any supporting evidence to determine if they qualify as a health institution. The MHRA will not determine if you can qualify as a health institution.

Clarification of important terms

Legal entity

The MDR 2002 describes that devices manufactured in accordance with the HIE must not be transferred to another legal entity. A legal entity is any organisation that has its own definition in law.

Example of legal entities, as established in the relevant legislation^{[footnote 1]}, would include:

• a hospital
• an NHS Trust/Board
• Integrated Care Boards (ICBs)
• a Health Board
• a Local Health Board or Authority
• Independent care providers e.g. Spire

Manufacturing a medical device

A health institution may be a manufacturer if it undertakes any of the following activities:

• the putting together of a device from raw materials or component parts
• the complete rebuilding of an existing device outside of the manufacturer’s instructions for use
• using the device for a different purpose to that intended by the manufacturer
• making a new device from used devices
• fully refurbishing a device
• device software development
• assigning a medical purpose to a product that is not already approved as a medical device
• putting together combinations of devices and other equipment outside the manufacturer’s instructions for use
• deviations from the manufacturer’s instructions for use that alter the function, performance or purpose of the device

Sub-contracted manufacture

Health institutions may use another party in the making of the device provided they have sufficient responsibility and control for the work of the other party. Control might include specifications for subcontractor quality management systems, regular audits, supply chain controls and mandatory notification of relevant changes. The responsibility, obligations and control for the work of the sub-contracted party remains the responsibility of the health institution, and they should ensure the leading practise guidelines are followed.

Modifying a device

The MDR 2002 apply whenever a device has been modified to such an extent that it can be considered as a new device. The modifications could include:

• deviations from the instructions for use that alter the function, performance or purpose of the device
• modifying a device for a new purpose
• altering the sample types, accessories or components or combining devices not specified by the manufacturer

The modification and use of the device should be verified against the original device when used as intended by the manufacturer to demonstrate and document whether the function, performance or purpose has been altered. Where a modified device is treated as a new device, the entity that modifies the device will be regarded as the manufacturer and will need to comply with the MDR 2002. If a modified device meets the aforementioned conditions, the HIE may be applied.

If a device is modified or adapted in accordance with the manufacturer’s intended purpose or instructions, the entity who modifies the device will be regarded as a user of the device, not the manufacturer. This includes devices designed and intended by the manufacturer to be:

• assembled, built or installed from modules or component parts,
• used together in combinations with other devices or equipment, or
• configured by the user of the device.

There are no specific rules about when a modified device should be treated as a new device, and every situation will need to be evaluated individually. The question is whether the device has been subject to changes which modify its original performance or safety. You may seek advice in specialised cases from the MHRA.

Determining whether the HIE can be used

The HIE applies to devices that are manufactured and used on patients within the same health institution’s premises, or its immediate vicinity and not transferred to a different legal entity.  

To help determine whether the HIE applies to your devices, please consider several illustrative examples.

Please consider:

Does the product have an intended medical purpose? Does the product meet the definition of a general medical device or an accessory to a medical device? If not, then it is not in scope of the MDR 2002 and therefore the HIE won’t be applicable.

Under the MDR 2002 Regulation 2, the definition of a medical device is as follows: 

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specially for diagnosis or therapeutic purposes or both and necessary for its proper application, which-

(a) is intended by the manufacturer to be used for human beings for the purpose of-

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or

(iv) control of conception; and

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.

For further guidance on determining if your product is a medical device, refer to: 

• Borderline products: medical devices and other products
• Borderline products: classifying medical devices and risk
• Software specific guidance – MHRA Software flowchart

Are you manufacturing a new device or modifying a device in a way that goes beyond the manufacturer’s instructions for use? If the changes stay within the instructions for use, it’s not considered manufacturing.

Is the device manufactured to a written prescription from a health care professional? If so, this will be a custom-made device and should follow the custom-made device requirements.

Custom-made devices

Custom-made devices are manufactured to a written prescription from a registered medical practitioner and intended for sole use by a particular patient and include moulded impressions. Examples of custom-made devices include prosthetic appliances, dental implants and orthopaedic footwear.

Custom-made devices can be taken home by individual patients. Health institutions that manufacture custom-made devices must follow the requirements set out in MDR 2002 regulation 15 or 28. The MHRA has published guidance explaining these requirements for custom made devices. These rules will be updated in future changes to the MDR 2002, and the MHRA will release new guidance to support future implementation. If a device meets the requirements for a custom-made device, this should take precedence over the HIE.

Off-label use

Off-label use refers to usage of a medical device for a purpose not covered in the manufacturer’s instructions for use. In separate guidance, the MHRA discourages off-label use, refer to Off-label use of a medical device.

Adaptable devices

Adaptable devices are assembled at the point of use or adjusted for individual patients in accordance with the limits set by the manufacturer’s instructions. Examples include fitting an orthopaedic implant or adjusting a prosthetic limb to match a patient’s socket. These activities, undertaken in line with the manufacturer’s instructions, are not in the scope of the HIE.

Assistive technologies and aids for daily living

Assistive technologies are products or systems that support and assist individuals with disabilities, restricted mobility or other impairments to perform functions that might otherwise be difficult or impossible. These products are sometimes regulated as medical devices, depending on their function and intended purpose. For example, if assistive technologies are intended to compensate for or alleviate a disability and have a medical intended purpose, they are regulated under the MDR 2002. Some assistive technologies can be custom-made devices and regulation 15 or 28 will apply. If these products do not have an intended medical purpose, they are not regulated as medical devices.

Please refer to guidance for more information on assistive technologies and aids for daily living.

Systems and procedure packs

Systems and procedure packs are combinations of products that are packaged together and intended to be used for a specific medical purpose. Health institutions that combine CE or UKCA marked medical devices may not be considered manufacturing or modification. If this is done in a manner that is compatible with the intend purpose of the devices and other equipment and within the limits of use specified by the manufacturer, these activities are not in the scope of the HIE.

Transfer of devices

Within different legal entities

A transfer refers to a sale, loan, hire, lease, gift, or any other type of legal transfer. The HIE does not apply to devices that are transferred between legal entities, either for a fee or free of charge. This would be considered placing the device on the market, and the health institution will be considered a manufacturer and must follow the MDR 2002, including undertaking conformity assessment and UKCA marking requirements.

The MHRA understands that sharing medical devices and knowledge is pivotal to enable innovation and ensuring equitable, high-quality patient care. The MHRA is exploring potential regulation updates to provide opportunities for device transfer between different legal entities under the HIE framework.  

Within the same legal entity

The HIE may be applied to devices that are transferred within the same legal entity and utilised on the premises of the same health institution or within its immediate vicinity, provided that a designated medical device responsible officer maintains oversight of these devices. This responsible individual must ensure that all devices manufactured and used within the legal entity comply with the leading practice guidelines.

For further guidance, refer to the Managing medical devices.

Use of devices outside health institution’s premises

Under the MDR 2002, devices that are manufactured within a health institution and then used outside that health institution’s premises or its immediate vicinity are not eligible for the HIE. This means that the HIE does not apply to devices that are taken away by patients for use in their own homes and the requirements of the MDR 2002 for commercially manufactured or for custom-made devices will apply depending on intended use.

The MHRA understands that care is now undertaken outside of a traditional hospital setting^{[footnote 2]}. To support the continuity of the ‘envelope of care’ provided to patients, many medical devices are designed not only for use within clinical environments but also in patients’ homes. The MHRA is exploring updates to the HIE regulatory framework with the goal to advise how health institutions can provide safe, effective, and innovative medical devices to patients - outside of a traditional healthcare setting. The MHRA will not consider this as an enforcement priority currently, provided the leading practice guidelines are followed.

1. Health and Care Act 2022, National Health Service (Scotland) Act 1978 and the National Health Service (Wales) Act 2006 ↩

2. In line with the UK Government’s 10 Year Health Plan for England and the Life Sciences Sector Plan, the Scottish Government’s Health and Social Care Service Renewal Framework 2025-2035 and the Welsh Government’s A healthier Wales: long term plan for health and social care ↩