If you are involved in healthcare technology or translational research, such as in the development or repurposing of a ‘product’ for the diagnosis, prevention, monitoring or treatment of a health condition, then these pages will help you understand the relevant regulation.
The precise regulatory path and evidence to demonstrate that a product is safe and effective is specific to the product, commercial intent and where you plan to market or trial your product. For the UK, the best place to get bespoke regulatory advice is from the Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Office. You may also have access to local expertise (like a research sponsor office, translation or technology transfer office).
EU Exit has changed the UK regulatory environment for healthcare products. You can find details in MHRA EU Exit guidance from 1 January 2021 and NHS Health Research Authority (HRA) guidance for health and social care researchers from 1 January 2021.
More change is coming. The MHRA medical devices consultation closed in November 2021, and new legislation is expected to come into force in July 2023. The MHRA have consulted on both the medical devices and clinical trials legislation and are currently analysing responses to both consultations.
You can learn more about the regulatory landscape for health research in understanding health research.
We also provide guidance on:
- using human samples in research
- using data about people in research – our Health Data Access Toolkit signposts the approvals you will need to access routinely collected NHS data.
In this section, you will find guidance on:
Medical devices and in vitro diagnostics
The definition of a medical device is very broad and encompasses products ranging from plasters to pacemakers. Standalone software and apps are also medical devices if they have a medical purpose.
In vitro diagnostics are devices that diagnose disease or certain conditions and include companion diagnostics (for example the identification of biomarkers to inform treatment options in precision medicine strategies).
Clinical trials of medicinal products and advanced therapies
UK clinical trials regulations apply to trials that test the safety or efficacy of medicinal products, including trials of medicines, vaccines, and advanced therapies such as gene or cell therapies. A comprehensive guide to the UK clinical trials regulations is in the Clinical Trials Toolkit. For studies that explore mechanisms of action, see our Experimental Medicine Toolkit.
Facilities and initiatives that can help with translation
A list of national and local facilities or initiatives that can help you develop your healthcare product.
Influencing new regulations
Find out what we are doing in the MRC Regulatory Support Centre to influence new regulations, and about the role that regulatory science can play.