Following the Health Select Committee’s majority report on 13 June, the Therapeutic Products Bill was pushed through Parliament under urgency and received the Royal Assent on 26 July. The Therapeutic Products Act will come into force on 1 September 2026 or such earlier date as may be set by Order in Council.
One element of the legislation that has changed which is relevant to providers and users of software in the medical field concerns the definition of “software as a medical device” (SaMD). Parliament has taken on board comments from many submitters and changed the definition of a SaMD so that it does not include software in a medical device (ie as a component part of the medical device). However, while such software is not of itself a medical device, the software will still be subject to the Act as a component part of that medical device.
The core elements of the definition of a SaMD remain, and capture (in a broad sense):
- software that meets the definition of a therapeutic product (ie intended for use in, on, or in relation to humans for a therapeutic purpose) without any associated hardware (other than an unrelated device that is needed solely to present a user interface); and
- software that is intended to be used to augment another product that is not a therapeutic product by making use of the functions, sensors, or other components of that product, and that other product together with the software meet the definition of a therapeutic product.
The term “therapeutic purpose” is also defined widely, and includes matters such as diagnosing and monitoring a disease, ailment, defect, or injury, and investigating, influencing, inhibiting, or modifying a human physiological process. Accordingly, much medical software will be regulated by the Act.
To help understand what sort of software is captured as a SaMD, the Select Committee report on the Bill gives as an example computer-aided detection (CAD) software that performs image processing to help detect breast cancer.
Given the wide scope for a SaMD, the Act also provides that Rules set by the Therapeutic Products Regulator can clarify whether particular software is a SaMD if it is otherwise unclear.
For more information on the Act generally, please see our earlier newsletter on the Bill as first introduced into Parliament, which can be accessed here, or get in touch with your usual Lane Neave lawyer.
