Guidance

Off-label use of a medical device

Updated 1 July 2023

This guidance is only relevant for medical devices on Great Britain (England, Wales and Scotland).

Please note that  CE-marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030.

The government has extended acceptance of CE marked devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

You should use medical devices as described by the manufacturer in the instructions. If you use the device in any other way, it’s considered ‘off-label’ use. Without the manufacturer’s approval this will be at your own risk and you or your employer could become liable for civil claims for damages from injured patients or their families if something goes wrong with the device.

Health and safety related legislation is also applicable to employers providing any equipment including devices for use in the workplace that the health and safety executive provide advice and guidance upon.

Off-label use of a device could lead to dangers including:

• adverse reactions
• inadequate sterilisation
• insufficient mechanical strength and/or structural integrity
• insufficient durability
• misuse due to lack of adequate training for the device

Medical devices without a CE or UKCA mark

You are advised to use medical devices with a UKCA mark, as this shows it has met the legal requirements for safety, quality and performance when it is used as the manufacturer instructs. Where devices are custom made for individual patients, or they are used for clinical trials they don’t need a CE mark. See more information on custom-made devices on the European Commission’s website.

MHRA may approve exceptional use of a non-compliant device on humanitarian grounds in rare cases. These devices don’t need a CE mark.

Modify medical devices

Some devices are designed to be modified. Manufacturers will provide instructions if a medical device can be modified in a specific way, for example orthotics.

Manufacturers will sometimes supply software updates or hardware modifications to improve the performance of a medical device or to correct a problem. They will either make the change themselves or provide detailed instructions for the user to make the modifications.

Single-use devices are not designed to be reused, for example, a syringe. A company that re-sterilizes a single-use device effectively becomes the manufacturer of the device and is responsible for getting it CE or UKCA marked. If the device is not CE or UKCA marked for its new intended purpose, it would be considered off-label use if you re-use it and it would be at your own risk.

No option but to use a device off-label

Although rare, it is possible that there is no medical device available for a procedure. In this case you should decide whether to use an existing medical device for a different purpose, modify a medical device for a new purpose or use a product for a medical purpose that is not CE or UKCA marked as a medical device.

You must balance the risks and benefits to the patient taking into account recommendations which include:

• carrying out a risk assessment and documenting it
• considering the ethical and legal implications
• implementing suitable precautions to minimise the risk
• reviewing the risk assessment at suitable periods
• getting approval from MHRA for exceptional use of non-complying devices (if necessary)

You must inform the patient during the consent procedure and make a note on their records that you will be using a medical device off-label.

Incompatible third party accessories

Check that any third party accessories are compatible with the original device(s) or the manufacturer may relate problems with the device to these accessories.

Examples of problems with off-label use

Medical device and use	Problems caused
IV cannula / catheter used as arterial catheter	On removal, a section of the catheter was left in the patient.
A modular head and stem for a total hip replacement (not an approved combination)	Failure earlier than expected.
Single-use insulin needles were used more than once contrary to the manufacturer’s instructions	Blockage and incorrect dosage reaching the patient.
A contact lens solution used during surgery rather than after surgery as stated in the instructions	Central toxic keratopathy.
A disposable temperature probe used via the nose rather than rectally / orally as stated in the instructions	Significant nose bleed.
A wheelchair modified to fit a docking system in a car	Damage to the wheelchair.
A defibrillator was unable to deliver a shock in manual or AED mode due to patient impedance being outside the specified range	Third-party electrodes used were not compatible with the defibrillator.
A user attempted to re-configure a Bain’s breathing system	Breathing system did not work properly due to wrong size oxygen connector being put back into the system.
An IVD test was used for a sample type other than that recommended by the manufacturer	You should not perform IVD tests on samples other than those recommended by the manufacturer. If there is no alternative the laboratory performing the test will be responsible for these tests. They should have strong data to support the test on non-approved sample types.
An IVD test used with incorrect software	Incorrect results generated or delay to treatment and/or diagnosis.