UK MHRA Ups Global Ambitions With IMDRF Role, Loses More Device Expertise
The in-transition MHRA is pressing ahead with its international devices remit while progress on the UK devices regulation is awaited.
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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.
Graeme Tunbridge is looking forward to a new career with notified body, BSI, after nearly two decades as a civil servant. But where does his departure leave the UK MHRA at a time of critical change?
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.