‘MDD+’ For The UK, As Future Devices Regulation Will Be A ‘Living Document’
Executive Summary
With the UK implementing sovereign device legislation after leaving the EU, there are opportunities for incorporating updated EU and US FDA provisions as regulation evolves.
You may also be interested in...
Interview: ‘More Forward Thinking’ Needed For UK IVD Industry As Brexit Looms
Incoming head of diagnostic regulation at the UK ABHI Steve Lee makes a plea for more detailed MHRA guidance around product registration requirements for the post-EU national market.
Interview: Has UK Medtech Happened Upon A Perfect Opportunity For Disruptive Regulatory Change?
ABHI’s Phil Brown looks beyond the immediate challenges for UK medtechs on being outside the EU, and to an innovation-friendly, patient-responsive system of future regulation.
UKCA Mark Will Be The Post-EU Route To The British Medtech Market In January 2021
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.