Clinical trials of medicines and medical devices

Clinical trials of medicines and medical devices

If your research looks at the effects of drugs or medical devices, it will be subject to UK and EU law.

In the UK, these trials are regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) and need NHS ethics approval through the Health Research Authority (HRA) before the study can start. 

Clinical investigation of an investigational medicinal product

A clinical trial of an "investigational medicinal product" (e.g. an investigation on human subjects, other than a non-invasive trial) usually looks to:

1. discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products;
2. find any adverse reactions;
3. study absorption, distribution, metabolism and excretion, with the aim of examining the safety and/or efficacy of those products.

You can find more advice by visiting the National Institute for Health Research’s Clinical Trials Toolkit.

This type of research will need approval from the University, the MHRA and the HRA before starting.

Clinical investigation of a medical device

A clinical investigation of a medical device usually includes any instrument, apparatus, appliance, material or other article, used alone or in with other items, including any software it might need, that is intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• Investigation, replacement or modification of the anatomy or of a physiological process
• Control of conception

It's main purpose must also not be done in or on the human body by pharmacological, immunological or metabolic methods, but can be helped by those means.

Visit the gov.uk website for information on notifying the MHRA about a clinical investigation for a medical device.

This type of research needs approval from the University, the MHRA and the HRA before it begins.

Staff who are thinking about doing this kind of research should look through the guidance from the MHRA