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English
$
USD
I will get your ce marked medical device UK market ready
Dapson
About this gig
Already CE marked and selling in the EU? Great Britain has its own rules now, and a CE mark alone doesn't guarantee market access. Many manufacturers assume EU compliance automatically covers the UK, then find their listing challenged or their MHRA registration missing.
I help CE-marked device manufacturers expand into the UK without starting their compliance file from scratch.
What you get:
- Gap analysis: what your existing EU technical file already covers vs what's UK-specific
- MHRA registration using your existing documentation as the base
- Guidance on UKCA marking timelines and whether it's mandatory for your device class
- UK Declaration of Conformity drafted from your EU DoC
- A prioritized action list so you're not redoing work you've already done
Best for: EU medical device manufacturers, distributors, and importers expanding into Great Britain for the first time.
Note: this is documentation and regulatory guidance support, not a substitute for a UK Responsible Person or Approved Body assessment where legally required.
Message me with your device class and current CE certificate details before ordering.
Get to know Dapson
Dapson
UK Regulatory, Compliance Cosmetics, Medical Devices,UKCA Docs
- FromUnited States
- Member sinceJul 2026
- Avg. response time1 hour
Languages
English
Expanding into the UK market means navigating SCPN cosmetic notification, Responsible Person rules, MHRA device registration, and UKCA documentation, get it wrong and you risk a blocked listing or customs hold.
I help cosmetic brands and medical device companies get UK paperwork right the first time, I research every submission against current MHRA/OPSS guidance rather than templates.
I explain what's actually required, handle the filing, and flag gaps before they become problems. Clear communication, no jargon dump.
Other Regulatory Compliance Consulting Services I Offer
FAQ
I already have a CE mark. Doesn't that cover the UK too?
Not automatically. Great Britain has its own regulatory framework post-Brexit. Some CE-marked devices can still be sold in GB for a transitional period, but MHRA registration is typically still required, and UKCA may apply depending on your device class.
Will you reuse my existing EU technical file, or start from scratch?
I work from your existing EU documentation and identify exactly what's UK-specific versus what already meets requirements. This is usually faster and cheaper than a from-scratch registration, which is the point of this gig.
How is this different from a standard MHRA registration gig?
Standard registration assumes you're starting fresh. This gig assumes you already have EU compliance in place and need the UK-specific gaps closed, not a full rebuild.
What device classes can you help with?
Class I through Class IIb. IVDs and higher-risk classes may need a scoped custom quote. Message me your classification before ordering.
Can you register as my UK Responsible Person?
I provide documentation and guidance support, not formal RP representation, since that role legally requires UK establishment. I can point you toward how to appoint a compliant partner if needed.
