The UK government has recently launched a consultation aiming to gather opinions around innovation and regulations of frameworks for software and artificial intelligence (AI) in the medical field.
Indeed, this consultation comes into effect as the new amendments are meant to be applied at the beginning of July 2023. By doing so, the government is hoping to allow early access to innovation around medical devices through data-driven assessments of the risks and benefits to patients. It wants to ensure that the regulations maximise the safety of patients as well as encourage innovation.
Besides, the consultation will also be introducing a framework for regulating software and AI as medical devices. Hence, this should help attract life sciences businesses and innovators without compromising on safety. The Medicines & Healthcare products Regulatory Agency (MHRA) stated that the proposal aims to develop and support responsible innovation in the medical field all the while protecting patients.
The report also underlines that Software as a medical device (SaMD) can be deployed to the UK by websites, app stores, and other electronics so that it can encourage discussion around the regulatory changes for these devices. Thus, the government is aiming to implement MHRA-endorsed websites where users are able to report adverse incidents regarding a medical device that is part of the proposals.
Finally, the agency is trying to introduce an airlock classification rule that will be monitoring and restrict the devices if it was flagged as high-risk. To meet the requirements, the government will then require that manufacturers of SaMD meet certain minimum security requirements.