Guidance

Illustrative examples

Published 17 December 2025

The following examples are designed to support health institutions in determining whether the HIE applies in different manufacturing scenarios. In the examples below:

• Condition 1 means that the device must only be used on the premises of the health institution that manufactured it or on premises in the immediate vicinity
• Condition 2 means that the device must not be transferred to another legal entity

Activity	Regulatory route	Rationale
General medical device examples
A hospital manufactures a medical device and then transfers it to an external organisation which shares the hospital’s premises.	The MDR 2002 must be followed.	Condition 2 is not met because the device has been transferred to another legal entity.
A university laboratory manufactures a device on a hospital’s premises as part of a joint health partnership. The device is then used by the hospital to test its patients.	In some cases, the HIE may be used.	In this example, the university laboratory and the hospital are a joint health partnership, which could be considered a single legal entity. Condition 2 would be met. In this example, the joint health partnership could be considered a health institution – condition 1 would be met.
A commercial manufacturer that shares premises with an NHS hospital manufactures a device which is then used by the hospital to test its patients.	The MDR 2002 must be followed.	In this example, the commercial manufacturer is a separate legal entity to the NHS hospital. Condition 2 is not met because the device has been transferred between legal entities.
A hospital laboratory develops a generic implantable device for use on patients within the hospital.	The MDR 2002 must be followed. This will not be an enforcement priority, provided leading practice guidelines are followed.	The device is intended to be taken away from the premises of the health institution (e.g. used in a patient’s home) so condition 1 would not be met.
A hospital clinical engineering department modifies a UKCA marked portable IV drip stand to allow more height adjustment outside the manufacturer’s IFU. The device is used within the same health institution’s premises.	The HIE can be used.	This aligns with MHRA guidance, which treats such modifications as creating a new device, meaning the hospital would be considered the manufacturer. In this example, conditions 1 and 2 are met and the HIE can be used.
A hospital maxillofacial department manufactures a bespoke facial prothesis for an individual patient. The device is manufactured in accordance with a prescription from a medical practitioner and is designed to stay with the patient.	This would be classified as a custom-made device and health institutions should follow the custom-made device guidance.	The HIE will not apply as this is a custom-made device.
A surgeon assembles an orthopaedic implant for an individual patient in accordance with the manufacturer’s IFU.	This activity is considered normal use of the device and the HIE is not applicable.	This is an adaptable device, assembled at the point of use or adapted for individual patients within the parameters for use of the device set out in the manufacturer’s instructions for use. In this case, the health institution is a user of a device.
An NHS rehabilitation service produces a custom-made wheelchair seat for an individual patient in accordance with a prescription (moulded impression) from a medical practitioner. The wheelchair is designed to be used outside the premises of manufacture (e.g. in the patient’s home).	This would be classified as a custom-made device and health institutions should follow the custom-made device guidance.	The HIE will not apply as this is a custom-made device.
An NHS rehabilitation service manufacturers a communication aid that is intended to stay with the patient but remains the property of the clinical service.	The MDR 2002 must be followed. This will not be an enforcement priority, provided leading practice guidelines are followed.	This is an assistive technology with an intended medical purpose (to alleviate the effects of a disability, specifically a communication impairment) so the MDR 2002 apply. The device is intended to stay with the patient (e.g. be taken home). Condition 1 is therefore not met.
A rehabilitation centre manufactures a device that enables a patient with arthritis to grip cutlery.	Not a medical device.	This product does not have an intended medical purpose and is an aid for daily living.
Activity	Regulatory route	Rationale
Software examples
An antibiotic dosage calculator software product is developed within an NHS Trust. It is only used by health care professionals from the same health institution and used within the same health institution’s premises.	The HIE can be used.	Conditions 1 and 2 are met.
A hospital develops a software product, and this is used by members of an external organisation which share the hospital’s premises.	The MDR 2002 must be followed.	Condition 2 is not met because the device has been transferred to another legal entity.
A software product is developed within an NHS Trust. This application is made available to patients for them to use at home (e.g. to input data/ access data etc.).	The MDR 2002 must be followed. This will not be an enforcement priority, provided leading practice guidelines are followed.	The device is intended to be used by the patient outside of the health institution’s premises (e.g. used at their home). Condition 1 is therefore not met.
Activity	Regulatory route	Rationale
Sterile services
A hospital’s sterile services department sterilises surgical instruments in accordance with the manufacturer’s instructions for use within its own NHS Trust.	Not in scope of the MDR 2002 – HIE therefore does not apply.	The manufacturer’s instructions are being followed by the NHS Trust.
A hospital’s sterile services department provides sterilisation services for another NHS Trust.	The MDR 2002 must be followed.	Condition 1 is not met.