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I will register your medical device mhra and ukca compliant fast
Brian Collins
About this gig
MHRA Registration & UKCA Compliance Specialist Medical Devices
Selling a medical device in the UK requires MHRA registration and UKCA marking handled correctly. A wrong classification code or incomplete file can delay market entry by months.
I help manufacturers, startups, and importers with MHRA registration, UKCA Declarations of Conformity, and MDR technical documentation so your device is legally ready for the UK market.
What you get:
- MHRA registration guidance and device classification (Class I, IIa, IIb, III)
- UKCA Declaration of Conformity preparation
- UKRP documentation and portal submission support
- MDR-aligned technical file structuring
- ISO 13485 documentation guidance
- Why work with me:
- Clear, accurate documentation no jargon, no guesswork
- Direct communication throughout
- Structured, audit-ready deliverables
I provide documentation, classification guidance, and portal submission support using your credentials. Not UK-established, and don't issue official approvals final decisions rest with the MHRA.
Message me for your device type and classification before ordering to confirm scope.
Get to know Brian Collins
Brian Collins
Regulatory Compliance Specialist, MHRA, UKCA, CPNP and SCPN Documentation Expert
- FromUnited States
- Member sinceApr 2026
- Avg. response time1 hour
Languages
English, French, German
Launching a medical device or cosmetic product in the UK and EU?
One compliance gap can mean instant MHRA rejection, a blocked cosmetic listing, or a shipment frozen at customs. I help manufacturers, importers, and startups get MHRA registered, UKCA compliant, and CPNP/SCPN notified accurately, without guesswork or delays.
You get correct classification, clean documentation, and submissions built to pass, so your product reaches buyers on schedule instead of stuck in review.
Message me with your product type and let's map out your compliance path today.
Other Regulatory Compliance Consulting Services I Offer
FAQ
Why was my previous submission rejected?
Usually, wrong classification or an incomplete technical file, I check both before you resubmit.
Can you guarantee MHRA approval?
No one can, that's the MHRA's call. I guarantee accurate, submission-ready documentation.
What's the difference between MHRA and UKCA?
MHRA registers your device; UKCA marks it as UK-compliant. You usually need both.
Do you offer UK Responsible Person services?
I review your setup and prepare the documentation your UKRP arrangement requires.
How fast will my device be ready to submit?
Within your package's delivery window, MHRA's own review time is separate.
I already have CE marking; do I still need UKCA?
In most cases, yes, for UK sales. I'll confirm exactly what your device needs.
What information do you need from me first?
Device description, intended use, and any current classification or documents.
Do you work with first-time UK market entrants?
Yes, most clients are launching their first device without prior UK compliance.
Can this work for Amazon or e-commerce listings?
Yes, documentation is prepared to meet UK/EU marketplace requirements too.
Should I message before ordering?
Yes, it confirms your device class, so you order the right package the first time.
