In his statement to the House of Lords on September 16, Lord Frost announced that “we will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and getting patients access to new lifesaving medicines more quickly. The MHRA which is a world class regulator as we know, is already reforming the medical devices regulations to create a world-leading regime in this area.” This provided a timely back-drop to the MHRA’s new publications on medical device software, and part of a broader agenda for regulatory change in the UK.

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