There are regulatory requirements that must be met before an innovation can enter the UK market are dependent on the type of innovation. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices are effective and safe.
Depending on the category of your innovation, there will be different levels of evaluation needed to get the required regulatory approval. For example, there are four different classes of medical devices ranging from low risk (Class I) to high risk (Class III).
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.