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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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.
Ukraine’s medical supply needs have evolved since Russia launched its military invasion of the country on 24 February. EU healthcare decision makers and the medical technology industry have since stood firm in their support of the besieged country, said MedTech Europe’s Jesús Rueda.