Software as a medical device (SaMD) manufacturers operating in the UK should note the new additional guidance from the UK regulator.
SaMD consists of software that is not part of a hardware medical device. It is also known as standalone software, medical apps or medical device software). SaMD is regulated under the same regulations as hardware medical devices – the Medical Device Regulations 2002.
The MHRA has published additional guidance on how the regulations apply to software in order to assist manufacturers with understanding their regulatory obligations. This gives examples of software and apps that the MHRA considers to fall within the definition of a medical device, as well as examples of software and apps that do not. Additional guidance has been provided on symptom checkers, clinical calculators and when software drives or influences the use of a device.
In early September, the MHRA updated its SaMD guidance with requirements to include field safety warnings and end-of-life notifications in Medical Device Software apps.
