Clinical Registries Database Mooted As UK Devices Bill Moves To Upper House
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.
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Certain Cumberlege Review recommendations are making their way into draft UK legislation as the government presses ahead in shaping the UK’s post-Brexit devices regulatory system.
The UK health care system is keen to reshape in light of the lessons learned from COVID-19, but it comes at a time when Brexit trade issues and device regulatory system changes are already muddying the waters.
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.