In order to be able to CE mark medical devices, manufacturers have to provide clinical data on said devices. One of the ways to provide such data is to conduct a clinical investigation.
In order to assist manufacturers on this matter, the UK Medicines and Health products Regulatory Agency (MHRA) released, on January 2020, the 5th version of their Guidance for manufacturers regarding Clinical Investigations of Medical Devices.
The Guidance outlines the UK regulatory framework to comply with when performing clinical investigations on medical devices, and includes an updated section on how to evaluate the necessity of conducting a clinical investigation.
Once said necessity is established, manufacturers can find guidance on the aspects to consider when performing such studies (number of devices, type of investigation, end points, etc.), as well as on the actions to follow in exceptional situations.
Finally, the document describes the application procedure to the MHRA when conducting a clinical investigation in the UK, as well as measures to take in the occurrence of adverse events involving devices undergoing clinical investigation.
Ana Rita Falcão
Regulatory Affairs Department
Do you need extra guidance on how to conduct or analyze the clinical data obtained for your device? Please do not hesitate to contact Obelis in order to receive further assistance!