Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System
Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.
You may also be interested in...
New MHRA guidance says the EU CE marking will continue to be used for devices and diagnostics in Great Britain until June 2023, and thereafter a standalone regulatory system will come into place.
The findings of the Cumberlege Review into how safety issues for three medical product groups were handled will shape debate on the UK’s new devices legislation, now going through parliament. The MHRA’s devices regulatory activity also comes in for scrutiny.
With Brexit less than a month old, Germany’s medtech industry has renewed its push for an MRA between the EU and UK in medtech regulation.