
MHRA Guidance on Software and AI as a Medical Device
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
The article highlights the key points related to the UK regulatory framework for clinical investigations involving medical devices.
The article describes in detail the approach the UK authority intends to apply when implementing amendments to the existing legal framework.
The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.
The article provides an overview of the current reporting requirements for healthcare products allowed to be used for clinical trials.
The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.