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I will do mhra registration and ukca marking compliance
Regulatory Affairs Compliance Specialist
Stop risking your UK market entry with regulatory delays. As an expert MHRA consultant, I specialize in seamless medical device and IVD registrations for global manufacturers and UKRPs. I handle the c...
About this Gig
SECURE UK ACCESS VIA MHRA REGISTRATION AND UKCA MARKING COMPLIANCE
Failing to meet post-Brexit regulatory demands stops your medical product sales completely.
Navigating the overlapping requirements of UKCA MARKING and MHRA REGISTRATION is notoriously confusing. A single mismatched classification or missing technical file leads to immediate application rejection, border seizures, and severe regulatory penalties. Trying to decode the MHRA portal alone burns weeks of valuable time while your competition secures the market.
Avoid these legal setbacks. I provide the strategic expert interference required to streamline your entire UK market-entry route.
I handle your complete MHRA product listings, manage necessary portal entries, and audit technical documentation for rigorous UKCA compliance. You secure seamless market clearance, eliminate legal vulnerabilities, and protect your global supply chain from unexpected delays.
Let's make your medical device or IVD fully authorized for legal sales across Great Britain.
Message me now to verify your device classification and unlock your UK market access.
Product stage:
Ideation
•
Prototype
•
Pre-Launch
Product type:
Hybrid Products
Industry:
Business
•
Health & wellness
•
Medical & pharmaceutical
FAQ
What is the difference between UKCA Marking and MHRA Registration?
UKCA marking is the certification process confirming your product meets UK safety legislations, while MHRA registration is the mandatory upload of that certified device into the UK government database before selling.
Can an overseas manufacturer complete this process independently?
No. International manufacturers must legally appoint a UK Responsible Person (UKRP) based in the UK to manage their UKCA technical compliance and execute the MHRA portal submission.
What device classifications do you handle under this gig?
I handle all tiers, including Class I, IIa, IIb, III medical devices, custom-made devices, and In Vitro Diagnostics (IVD) entering Great Britain.
Are government portal submission fees included in your packages?
No. My pricing covers professional regulatory consulting, document preparation, and submission handling. The official MHRA statutory fees must be paid directly on the portal.
How long will it take to get my official MHRA registration confirmation?
Once submitted via the portal, the MHRA typically reviews and approves listings within 5 to 10 business days, provided the documentation is flawless.
What documentation do I need to provide to start?
You need your existing CE technical files, Declaration of Conformity, product labeling draft, and ISO 13485 certificates if applicable.
Can you help update my current listings to meet the new UKCA regulations?
Yes. If you have active registrations that require modification or compliance alignment with updated UK legislation, I can manage the entire update seamlessly.
Will you act as our corporate UKRP under this gig?
Yes, my Premium package is designed to provide full UKRP legal representation alongside registration services for international brands.
What happens if my technical file has compliance gaps?
I audit your documentation in advance during the initial phase. If gaps are found, I provide direct instructions to fix them before submitting to prevent rejection.
Do I need a separate registration for Northern Ireland?
Northern Ireland follows distinct rules linked to the CE mark. I will structure your compliance framework based precisely on your exact UK distribution strategy.
