‘MDD+’ For The UK, As Future Devices Regulation Will Be A ‘Living Document’
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.
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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.
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.
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.