UK Consultation: Device Regulator Seeks To Balance Innovation And Patient Safety
Innovative device access pathways are on the agenda of both NICE and the MHRA, but the UK regulator’s new chief safety officer stresses that patient safety first and foremost will shape its work programs in the post-EU era.
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The UK's medtech regulatory consultation has closed and the MHRA must now assess the views of stakeholders on the 465 questions designed to help shape the foundations of a future-proofed regulatory system. But time is tight, as speakers at the ABHI’s annual regulatory conference were at pains to stress.
The Cumberlege Review of patient safety delivered a damning verdict on the UK’s health system. Its recommendations must be acted on, says a consensus of stakeholders.
The UK’s post-EU standalone legislation for medical devices has continued its parliamentary journey, reaching the upper house this week. Debate on a clinical registries policy paper has begun.