Transparency and integrity
Clear, honest communication on every regulatory question. We document every decision we make on your behalf, so your UK file is always audit-ready.
UK Responsible Person
Your UK Responsible
Person for medical devices.
If you manufacture medical devices outside the UK, the law requires a UK Responsible Person to put them on the Great Britain market. Medenico takes that role end to end: MHRA registration, vigilance, labelling review and post-market surveillance, handled by one accountable UK team.
Do you need a UKRP?
If you manufacture outside the UK, the answer is yes.
Under the UK Medical Devices Regulations 2002, any manufacturer established overseas must appoint a single UK Responsible Person to register its devices and act for it before the MHRA. It applies across Class I, IIa, IIb, III and IVDs, whether your devices are CE or UKCA marked.
You need a UKRP if:
- You are the legal manufacturer of a medical device or IVD.
- Your business is established outside the United Kingdom.
- You place, or intend to place, those devices on the Great Britain market.
- You do not already have a UK-established entity acting as your Responsible Person.
CE-marked devices remain accepted on the Great Britain market until 30 June 2030 at the latest, and the MHRA is consulting on recognising CE marking indefinitely. The UKRP obligation, however, applies today.
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.
-
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 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.
How onboarding works
From enquiry to registered, in weeks not months.
01
Scope and quotation
Tell us your devices, their risk classes and what documentation you hold. We send a fixed quotation, usually within one working day, so you know the cost up front.
02
Letter of Designation
We issue the contract that appoints Medenico as your sole and exclusive UK Responsible Person. Typically signed within three to five working days.
03
MHRA registration
We register your devices with the MHRA against the agreed scope. Registrations are commonly live within two to four weeks of submission.
04
Ongoing UKRP duties
We hold your technical file, handle vigilance and post-market surveillance, and act as your UK point of contact for as long as your devices are on the market.
Most manufacturers are fully onboarded within four to eight weeks of providing their documentation. We tell you what we need up front, so nothing stalls.
Fees
Fixed, transparent fees. No surprises.
We price every UKRP engagement up front against a published schedule, so you know the full cost before you commit. There are three parts.
One-off set-up
A single onboarding fee per manufacturer, covering the Letter of Designation and your initial MHRA registration.
Annual retainer
A fixed yearly fee per manufacturer for holding the UKRP role, tiered by the highest device class in your portfolio.
MHRA statutory fee
The Government registration charge, billed at cost with no mark-up. Pro-rated in your first year.
Ad-hoc work — vigilance events, additional device registrations, labelling and IFU review — is quoted up front against the same schedule. All fees exclude VAT.
FAQ
UK Responsible Person, in plain terms.
- What is a UK Responsible Person (UKRP)?
- A UK Responsible Person is a legal entity established in the UK that an overseas manufacturer must appoint to register its medical devices with the MHRA and act on its behalf on UK regulatory matters. The role and its duties are set out in the UK Medical Devices Regulations 2002 (as amended).
- Who needs a UK Responsible Person?
- Any manufacturer established outside the United Kingdom that places medical devices or IVDs on the Great Britain market. If you are based overseas, you must appoint a single UKRP to cover all of your devices before they can be registered.
- Is CE marking still accepted in the UK?
- Yes. CE-marked medical devices are accepted on the Great Britain market until 30 June 2030 at the latest, depending on device type, and the MHRA has launched a consultation on recognising CE marking indefinitely. Either way, the UK Responsible Person requirement applies now.
- How long does it take to appoint Medenico and register?
- We issue the Letter of Designation within three to five working days, and MHRA registration is commonly live within two to four weeks of submission. Most manufacturers are fully onboarded within four to eight weeks of providing their documentation.
- Can I switch my existing UK Responsible Person to Medenico?
- Yes. We manage the transfer, notify the MHRA and, where applicable, your notified body, and take over your registrations and record-keeping. We plan the change so there is no gap in your UKRP coverage.
- What documents do you need from us?
- Your manufacturer details, the signed Letter of Designation, the CE certificate or Declaration of Conformity for each device, technical documentation, device identifiers, labelling and instructions-for-use artwork, and your post-market surveillance plan.
- How much does a UKRP cost?
- Pricing is a one-off set-up fee, a fixed annual retainer tiered by device class, and the MHRA statutory fee billed at cost. We quote each engagement individually and up front, so the cost is predictable and you pay only for the devices and classes you place on the market.
- Where is Medenico based?
- Medenico Ltd is registered in Sevenoaks, Kent, United Kingdom (company number 15628036) and is registered with the MHRA as a UK Responsible Person.
Partner with Medenico
Get a UKRP quote
this week.
Tell us your devices and their risk classes and we will send a fixed quotation, usually within one working day. No obligation, and no charge for the conversation.
Registered
- Medenico Ltd, registered UK Responsible Person.
- Headquartered in Sevenoaks, Kent.
- Company number 15628036 · MHRA registered.