UK MHRA Full Steam Ahead On Transformation Plan But Medtech Regulation Still Held Up
UK regulatory agency’s One Agency approach on cusp of going live
Teething troubles including staffing issues and a hold-up in the progress of the post-Brexit medical devices statutory instruments have beset the UK MHRA as it transforms to a new lifecycle-based regulatory agency that puts primacy on patient safety. But there is much to celebrate, says chief executive June Raine.
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26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.
The in-transition MHRA is pressing ahead with its international devices remit while progress on the UK devices regulation is awaited.
In its just-released real-world evidence framework, NICE assesses the role and value of data collected outside highly-controlled clinical studies in driving more innovation towards health care professionals.