Your company is outside the UK. You sell or intend to sell medical devices/IVDs in Great Britain (England, Scotland, Wales). Registered with: MHRA Provided by: Cyberpan Support

Your company is outside the EU. You CE-mark medical devices/IVDs for sale in any EU member state. Registered with: EUDAMED Provided by: UKALIA Ltd

UKRP and EC-REP services for medical device manufacturers

Fast, practical & properly registered — so you can place your products on UK and EU markets without delay

What we do

UK Responsible Person

Core Service

If your company is based outside the UK and you sell medical devices or IVDs in Great Britain, you are legally required to appoint a UK Responsible Person.

How we help

We are registered with the MHRA and act as your UKRP — managing device registration, vigilance reporting, and regulatory correspondence on your behalf.

Core Service

MHRA Registration

Placing medical devices or IVDs on the Great Britain market requires registration with the MHRA.

Our role

We handle device listing, maintain your registration records, and manage any required submissions or updates — as part of a UKRP appointment or as a standalone service if you already have a UKRP in place.

EU Authorised Representative

Core Service

If your company is based outside the EU and you CE-mark medical devices or IVDs for any EU market, you must appoint an Authorised Representative.

How we help

We act as your EC-REP through UKALIA Ltd, registered in Belfast under the NI Protocol — giving you access to all EU-27 markets with the advantage of Northern Ireland’s dual regulatory standing.

Core Service

EUDAMED Registration

Registration in EUDAMED is a legal requirement for manufacturers and their representatives under EU MDR and IVDR.

Our role

We handle actor registration, device listing, UDI management, and ongoing data maintenance — including the parts of EUDAMED’s IT systems that most advisors have never had to navigate themselves.

How it works

STEP 1

Enquire or appoint directly

Send an enquiry or — if you already know what you need — complete the letter of appointment directly.

STEP 2

Scope and documentation

We agree the mandate and service terms.

We prepare the regulatory documentation, MHRA or EUDAMED registrations, and any device-specific submissions required.

STEP 3

Ongoing representation

We act as your registered representative for the duration of the appointment — managing vigilance reporting, regulatory correspondence, EUDAMED data management, and any compliance updates as regulations evolve.

Also Available

Energy Performance Services

For commercial and industrial energy users qualifying under ESOS or the UK Energy Regulations 2024.

Our role

We provide energy data analysis, compliance route-mapping, and where larger capital projects are required, co-ordination with specialist M&E partners for full EPCC delivery.

Also Available

Testing, Inspection & Certification

Available to manufacturers, contractors, and operators requiring third-party inspection for market access, insurance, or regulatory purposes.

Our role

Independent inspection and certification for products, plant, and processes — covering machinery conformity, pressure equipment, lifting equipment, and CE/UKCA marking.

Also Available

Second & Third-Party Auditing

Second-party audits assess your suppliers. Third-party audits provide independent certification-level assessment.

Our role

Management system audits against ISO 9001, 13485, 14001, 45001, 50001, and 27001 — delivered on-site or remotely. Reports are structured to support management review and regulatory inspection readiness from day one.

Our approach is evidence-led, structured & designed for real-world application — not theory.

We are not a consultancy

We do not sell advice and then charge separately for delivery. We act as your representative, execute the registrations, and manage the ongoing obligations. Fixed fees. Defined scope. No surprises.

We reduce your time to market

Competitor services often add process layers and scope creep that delay appointments and registrations. We move quickly, work to your timeline, and avoid manufacturing complexity where none is needed.

Properly registered

We hold active UKRP and EC-REP registrations. This is not a resold or white-labelled service. Your appointment goes through the correct legal entity, correctly registered with the relevant authority.

Both markets from one engagement

A US, Japanese, or Australian manufacturer needs both a UKRP and an EC-REP. We manage both through the appropriate entities — co-ordinated, not duplicated.

Field experience behind the desk

Our leadership has operated inside the environments it now supports — offshore, clinical, laboratory, manufacturing. When a regulatory question is genuinely complex, the answer comes from experience, not a template.

Sector Snapshot

Medical device manufacturers, IVD producers, pharmaceutical groups, NHS and private healthcare providers, sterile processing and laboratory environments.

Environments

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Compliance

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Offshore and subsurface operators, mechanical and electrical systems, pressure equipment environments, energy management and efficiency programmes.

Systems

More Efficient

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Complex manufacturers, precision engineering, calibration and testing facilities, production and QC environments, logistics and warehousing operations.

Year's Experience

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Production Boost

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Contractors and principal designers with machinery conformity, pressure testing, and occupational health and safety obligations.

Projects Completed

Less Risk

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Law firms, professional services organisations, and regulated advisors requiring information security, ISO 27001 support, or third-party audit services.

Audits

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Compliance

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