Transparency and integrity
Clear, honest communication on every regulatory question. We hold ourselves to a high ethical standard and document every decision we make on your behalf.
UKRP services
Your UK Responsible
Person, post-Brexit.
Medenico provides comprehensive UK Responsible Person services for overseas medical device manufacturers placing products on the UK market. MHRA registration, vigilance reporting, labelling review and ongoing post-market surveillance — handled end-to-end by one accountable UK team.
The framework
Compliance and market access, after Brexit.
The UK Medical Devices Regulations require any overseas manufacturer placing devices on the British market to appoint a UK Responsible Person — a registered entity established in the UK that takes on defined regulatory duties on the manufacturer's behalf.
Medenico is one of those entities. We handle the regulatory layer your UK launch depends on, so that your team can stay focused on the device, the clinical evidence and the route to the people who use it. One UK address, one accountable team, one continuous record.
Why Medenico
Three commitments
we make to every partner.
End-to-end support
From initial MHRA registration through ongoing post-market surveillance, we manage the full regulatory lifecycle. One accountable team, one paper trail.
A single point of contact
As your registered UKRP, we are your interface with the MHRA. We field correspondence, file submissions and route Competent Authority queries on your behalf.
What we cover
The full regulatory
lifecycle.
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MHRA device registration
We register your devices with the MHRA, ensuring documentation is accurate, complete and submitted on time. All risk classes — Class I, IIa, IIb and III — and IVDs.
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Compliance assurance
We verify your devices meet UK requirements and assist with declarations of conformity and appropriate CE or UKCA marking, working with your notified body where applicable.
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Technical documentation
We hold a copy of your technical file at our UK address and make it available to the MHRA on request, keeping you continuously compliant with UKRP record-keeping requirements.
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Vigilance and incident reporting
We monitor incidents involving your devices, report them to the MHRA within applicable deadlines, and assist with field safety corrective actions to protect patients and your market position.
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Labelling and packaging review
We ensure device labelling, outer packaging and instructions for use carry our name and UK address as required, and review them against UK-language and regulatory expectations pre-launch.
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Post-market surveillance
We support your ongoing surveillance activities, helping you address trends and issues that arise during the device lifecycle and feeding back into your technical documentation.
Partner with Medenico
UK market access,
held to our own standards.
Appointing Medenico as your UKRP means partnering with a team that takes ownership of your UK regulatory position. We understand the post-Brexit framework, we work to the rhythm of MHRA expectations, and we treat your compliance as our own. Tell us about your device and we will route you to the right specialist within one working day.
Registered
- Medenico Ltd., registered UK Responsible Person.
- Headquartered in Sevenoaks, Kent.
- MHRA registered.