Moved by
Lord Freyberg
83: Clause 12, page 7, line 28, at end insert—
“(3) Within 12 months of this section coming into force, the Secretary of State must initiate a comprehensive technical review of the definition of “medical device” under the Medical Devices Regulations 2002 with a view to addressing the inclusion of artificial intelligence software and algorithms including methodologies for the interpretation of data and associated technical architecture in medical devices.”
Member’s explanatory statement
This amendment seeks to improve how the Bill addresses new technologies which have significant potential for harm, aligning with and improving on the EU and US equivalents.