MHRA Updates Guidance on Custom-Made Devices in Great Britain
The Medicines and Healthcare products Regulatory Agency has updated its guidance “Custom-made devices in Great Britain”, dated 20 July 2026.
The guidance applies to medical devices placed on the market in Great Britain, covering England, Wales and Scotland. It is intended to help manufacturers understand compliance requirements for custom-made medical devices and custom-made active implantable medical devices under the UK MDR 2002.
Definition of Custom-Made Devices
According to the guidance, a custom-made device is manufactured specifically in accordance with a written prescription from a registered medical practitioner or another authorised professional.
The device must be intended for the sole use of a particular patient.
The MHRA also clarifies that mass-produced devices which need to be adapted to meet the specific requirements of a healthcare professional are not considered custom-made devices.
Examples of Custom-Made Devices
The guidance provides examples of products that may be considered custom-made devices.
These include dental appliances, artificial eyes, cosmetic shells, maxillofacial prostheses, hearing aid inserts and moulds, in-the-ear aids, orthopaedic footwear, patient-specific joint replacement implants, prosthetics and orthotics.
Conformity Assessment and UKCA Marking
Manufacturers of custom-made devices must follow the relevant requirements of the UK MDR 2002.
The guidance notes that custom-made devices must meet the applicable essential requirements, including those related to materials, biological properties, infection control, construction, radiation protection, energy sources and information supplied by the manufacturer.
Custom-made devices and custom-made active implantable medical devices do not need to be UKCA marked when first placed on the market or put into service. However, they must still comply with the relevant provisions of the UK MDR 2002.
The guidance also states that manufacturers of custom-made devices do not require the intervention of a UK Approved Body.
Statement for Custom-Made Devices
Manufacturers must draw up and maintain documentation relating to the custom-made device.
For certain custom-made devices, including those that would be classified as Class IIa, IIb or III, or active implantable medical devices, the device must be accompanied by a statement.
This statement should include information such as device identification, confirmation that the device is intended for exclusive use by a particular patient, details of the qualified prescriber, specific design features, conformity with relevant essential requirements, and the name and address of the manufacturer.
Post-Market Surveillance and Vigilance
The guidance reflects the strengthened post-market surveillance requirements introduced for medical devices in Great Britain.
Manufacturers of custom-made devices must maintain a post-market surveillance system for each device placed on the market or put into service.
The PMS system should be used to update relevant information, including instructions for use and labelling, design and manufacturing information, risk analysis, performance evaluation data and technical documentation.
Manufacturers must also report incidents resulting from the constituents or design of the device where they pose a serious risk to public health, or where the manufacturer initiates a field safety corrective action, such as a recall.
Registration
Manufacturers of custom-made devices, or their UK Responsible Person, must register with the MHRA if they place custom-made devices on the market.
Registration must include a description of the devices concerned and the business address. This applies to both general medical devices and active implantable medical devices.
Impact on Medical Device Manufacturers
For manufacturers of custom-made devices in Great Britain, the updated guidance reinforces the need to maintain clear documentation, appropriate conformity assessment processes and effective post-market surveillance.
Manufacturers should pay particular attention to:
whether the device meets the definition of a custom-made device;
prescription and patient-specific design requirements;
applicable UK MDR 2002 essential requirements;
labelling and information supplied with the device;
statement requirements for relevant custom-made devices;
PMS obligations from 16 June 2025;
vigilance and reporting requirements;
MHRA registration obligations;
the role of the UK Responsible Person where applicable.
For manufacturers, the guidance highlights that custom-made devices may be exempt from UKCA marking, but they remain subject to important regulatory, documentation, PMS and registration requirements.
