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$
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I will handle your mhra and ukca device registration
Dapson
About this gig
Placing a medical device on the Great Britain market? Devices must be registered with the MHRA, and most now need UKCA marking and technical documentation, not just a CE mark.
Missing a piece here can mean your product gets flagged at market surveillance, not just customs.
I help manufacturers and importers get their paperwork right the first time.
What you get:
- MHRA device registration support (Class I, IIa, IIb, or IVD)
- UKCA marking documentation: technical file structure, UK Declaration of Conformity
- Gap analysis between your existing CE/MDR file and UK requirements
- Guidance on whether UKCA is actually mandatory for your product category
- A clear checklist of what's missing before you submit
Best for: medical device manufacturers, importers, and distributors entering the UK market or maintaining dual UK/EU compliance.
Note: this is documentation and regulatory guidance support, not a substitute for a UK Responsible Person or Approved Body assessment where one is legally required.
Message me with your device classification before ordering so I can scope this correctly.
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
Do I need UKCA marking if I already have a CE mark?
It depends on your device category. Many general devices can still use CE marking indefinitely in Great Britain, but some categories require UKCA. I'll check your specific classification before we start so you're not paying for marking you don't need.
What's the difference between MHRA registration and UKCA marking?
MHRA registration lists your device with the UK regulator so it can legally be placed on the market. UKCA marking is the conformity mark itself, backed by technical documentation. Most devices need both, but the requirements differ by class.
What device classifications do you cover?
Class I, IIa, and IIb devices, plus in-vitro diagnostics (IVD). Higher classes involve more technical documentation, so message me with your classification first so I can scope the right package.
How long does MHRA registration take?
Preparing your documentation typically takes 3-7 business days depending on package and device class. The MHRA's own processing time is separate and outside my control, but I'll make sure your submission is complete the first time.
Can you act as my UK Responsible Person for medical devices?
I provide documentation and regulatory guidance support, not formal RP representation. That role legally requires UK establishment. If you need one, I can point you toward how to appoint a compliant partner.
