Lindsay Hartland
Neuromodulation Executive Search & Commercialization Partner | Paving the Path for NeuroTech Start-ups | Board Advisor | Hanison Green Founder | Touchdown Neurotech Co-founder | RFC & RMC Co-founder | Changer of Lives
Henley Business School Hanison Green Ltd
London, England, United Kingdom
Big news for #Medtech innovators.....
The UK has recently confirmed it will recognise approvals from trusted regulators (FDA, CE mark, and others) as part of its new medical device framework.
This means if your device already has FDA or CE approval, the MHRA won’t make you start from scratch. Instead, they’ll use those approvals as a fast-track into the UK market.
This isn’t a free pass; the MHRA will still apply UK-specific checks, nonetheless it’s a huge shift.
It means:
✅ Faster access for patients to cutting-edge devices
✅ Lower barriers for innovators scaling into the UK
✅ Less duplication for companies already navigating complex regulatory pathways
For #neurotech start-ups in my network, this is an opportunity hiding in plain sight.
If you’re already FDA-cleared, the UK just became a more attractive early market...... and if you’re CE-marked, you now have a smoother bridge into the NHS.
My advice:
Don’t treat this as “regulatory admin.” Treat it as a commercial lever.
Build UK entry into your roadmap earlier, because the NHS is hungry for solutions that improve outcomes and reduce system strain.
Position your device not just as “approved,” but as globally validated. That narrative matters when you’re pitching to investors, clinicians, and procurement teams.
The innovators who move first will set the tone. The rest will be playing catch-up.
For help or advice on this, then talk to me or either of my Touchdown Neurotech co-founders Iain Strickland PhD or Laurent Baranzelli.
At TD we have a proven track record of achieving market access and commercialization of non-invasive Neuromod devices in the UK.
https://lnkd.in/eTKyS5jF
VERY interesting!!
Neuromodulation Executive Search & Commercialization Partner | Paving the Path for NeuroTech Start-ups | Board Advisor | Hanison Green Founder | Touchdown Neurotech Co-founder | RFC & RMC Co-founder | Changer of Lives
Henley Business School Hanison Green Ltd
London, England, United Kingdom
Big news for #Medtech innovators.....
The UK has recently confirmed it will recognise approvals from trusted regulators (FDA, CE mark, and others) as part of its new medical device framework.
This means if your device already has FDA or CE approval, the MHRA won’t make you start from scratch. Instead, they’ll use those approvals as a fast-track into the UK market.
This isn’t a free pass; the MHRA will still apply UK-specific checks, nonetheless it’s a huge shift.
It means:
✅ Faster access for patients to cutting-edge devices
✅ Lower barriers for innovators scaling into the UK
✅ Less duplication for companies already navigating complex regulatory pathways
For #neurotech start-ups in my network, this is an opportunity hiding in plain sight.
If you’re already FDA-cleared, the UK just became a more attractive early market...... and if you’re CE-marked, you now have a smoother bridge into the NHS.
My advice:
Don’t treat this as “regulatory admin.” Treat it as a commercial lever.
Build UK entry into your roadmap earlier, because the NHS is hungry for solutions that improve outcomes and reduce system strain.
Position your device not just as “approved,” but as globally validated. That narrative matters when you’re pitching to investors, clinicians, and procurement teams.
The innovators who move first will set the tone. The rest will be playing catch-up.
For help or advice on this, then talk to me or either of my Touchdown Neurotech co-founders Iain Strickland PhD or Laurent Baranzelli.
At TD we have a proven track record of achieving market access and commercialization of non-invasive Neuromod devices in the UK.
https://lnkd.in/eTKyS5jF
VERY interesting!!
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