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
Executive Summary
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.
You may also be interested in...
MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance
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.
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.
The Sustainability Stakes Are Rising: ‘We Cannot Recycle Our Way Out Of This’
The journey to Net Zero, described as ‘the defining issue of our time,’ will get harder in the coming decade. Failure to keep up the pressure will result in more long-term health conditions, increasing deaths and higher costs. The UK NHS is a Net Zero exemplar globally, but without a systemic approach, its compliance efforts could stutter.