Regulation

There are regulatory requirements that must be met before an innovation can enter the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices are effective and safe. All medical devices, including software, must be registered with the MHRA before they can be sold in the UK.

Medical devices are assigned one of four different classes, ranging from low risk (Class I) to high risk (Class III). Depending on the classification of your innovation, there will be different levels of evaluation required for the necessary regulatory approval.

Examples of medical device classification:

Class I: Low risk (examination lights, bandages, syringes without needles).

Class IIa: Medium risk (standard hearing aids, suture needles and short-term corrective lenses). Includes software which provides information that may be used to make a diagnosis, clinical decision or for therapeutic purposes.

Class IIb: Medium risk (apnoea monitors, ventilators, surgical lasers). Software classification is similar to Class IIa, but includes software which informs clinical decisions that might result in serious harm or require a surgical intervention.

Class III: Higher risk (pacemakers, total hip joint replacement system, breast implants, contraceptive IUDs, devices containing medicinal substances). Includes software which informs clinical decisions that could lead to irreversible deterioration of a health condition or death.

Digital health tools that may be medical devices include:

  • patient-facing apps that enable self-management or remote monitoring of medical conditions such as diabetes or depression
  • symptom checkers that offer medical advice based on information entered by a patient
  • online digital tools to assist in diagnosis, e.g. a cloud-based software programme that identifies melanomas from dermatoscope images
  • an app that advises on insulin dose based on a diabetic patient’s blood glucose level and dietary input
  • medical calculators and algorithms

If you would like to understand what regulations apply to digital health technologies (DHTs), and how to meet them, visit the AI and Digital Regulations Service. You can learn more about what regulations to follow and how to evaluate effectiveness. The website is aimed at both developers of AI and digital technology, or adopters who will buy or use DHTs in health and social care.

You can access support from the AI and Digital Regulations Service through the NHS Innovation Service.