UK Custom-made Device Statement

In accordance with the MHRA's guidance on custom-made devices in Great Britain, manufacturers are required to prepare a statement that includes the following essential elements.

Custom made statement for UK:

1. Data enabling the identification of the specific device, such as its description, serial number, order number, and generic name.

2. A declaration indicating that the device is intended exclusively for use by a specific patient, accompanied by the patient's name (or an identification number that maintains patient confidentiality but can be traced back to the named patient through records).

3. The name and workplace, if applicable, of the qualified person, medical practitioner, or authorized individual who issued the prescription.

4. Detailed specifications of the device, as outlined in the relevant prescription, extracting and defining its unique features.

5. A statement affirming that the device complies with all relevant essential requirements. If any requirements are not met, the grounds for considering the device safe for use should be provided.

6. The manufacturer's name and address.

For visual references and examples of custom-made statements, the MHRA offers PDF samples, available: HERE.

Do you want to have a Custom made registered in the MHRA (UK)? Check this information!