Software as medical device
The first step in the digital therapies journey is to determine whether the product you are developing is purely software or software that qualifies as medical device.
Standalone software (including artificial intelligence) becomes a digital therapy and medical device when its intended purpose is medical.
The legal definition of a medical purpose includes:
- the prevention, diagnosis, monitoring, treatment, and alleviation of a disease, injury, or handicap;
- compensation for an injury or handicap;
- investigation, replacement, or modification of the anatomy or of a physiological purpose; - or control of conception.
In the UK, the designated authority that administers and enforces the law on medical devices is the Medicines and Healthcare products Regulatory Agency (MHRA), whose remit is to ensure device safety, quality, and effectiveness or efficacy.
The key legislation is the Medical Devices Regulation 2002. All medical devices must be registered with MHRA and obtain a UK Conformity Assessment (UKCA) mark before they can be placed on the UK market. More details on both are provided later on. If you are unsure whether your software qualifies as medical device, MHRA has issued detailed guidance to help manufacturers decide. You can also look at case studies.
If your product is a medical device, then the next step is to classify the associated risks.