By Rita Hendricusdottir, RegMetrics
When testing your device on human subjects, understanding the regulatory line between a general product and a medical device is critical. Regulatory authorisation from MHRA is mandatory only when your study qualifies as a Clinical Investigation. The study is a clinical investigation if it involves human subjects, the device is used for a medical purpose (e.g., diagnosis, treatment, or monitoring of a disease / injury), AND the objective is to determine its clinical performance, effectiveness, or safety. The intended purpose is the key distinction: a general wellness device, for example testing a new fitness bike with the intended purpose of only maintaining a healthy lifestyle, does not have any medical claims, and therefore this study is not a clinical investigation and does not require regulatory authorisation (though ethical approval is still always required).
The crucial difference lies in that intended purpose. For example, testing a new fitness bike that is intended for rehabilitation for people with muscle injury or post-surgery, does have a medical purpose and falls within the scope of a medical device. Before performing this study, you will need authorisation from MHRA as it is now classified as a clinical investigation.
Research Study
A study can qualify as a research study / research tool, if the device is used on humans, but not being used for a medical purpose or to test the device’s clinical performance, effectiveness, or safety.
For example, if the objectives of the study are to produce generalisable knowledge of the human body or certain condition, the study is likely to be qualified as a research tool. Once it has been determined that the device / study is a research tool, it is important that there are no claims or references to a medical purpose in the study documentation. For example, the study information should not imply that a participant’s pathological diagnosis will be updated, or that their disease state will be improved, by participation in the study. Research studies and tools do not require approval from MHRA.
However, if these studies explicitly or implicitly make the claims that a participant’s pathological diagnosis will be updated, or that their disease state will be improved then this study and device is being used for a medical purpose and is a clinical investigation which requires approval from MHRA.
Always assess the device’s intended use and the study’s specific aims (performance, safety, or effectiveness) to determine your path forward and avoid unnecessary regulatory delays or, worse, non-compliance.
Read the full article about clinical investigation, written by RegMetrics.