Fast, practical & properly registered — so you can place your products on UK and EU markets without delay
We are a registered UK Responsible Person (UKRP) and EU Authorised Representative (EC-REP), handling your MHRA registration, EUDAMED submissions, and regulatory documentation — without the consultancy overhead.
Registered UKRP
Registered EC-REP
MHRA registered
EUDAMED registered
NI Protocol compliant
Operating since the 1980s
If your company is based outside the United Kingdom and you place medical devices or IVDs on the GB market, you are legally required to appoint a UK Responsible Person.
We are registered with the MHRA and act as your UKRP — handling registration, vigilance, and regulatory correspondence on your behalf.
If your company is based outside the European Union and you CE-mark medical devices or IVDs for the EU market, you must appoint an EU Authorised Representative.
We act as your EC-REP through UKALIA Ltd, registered in Belfast, Northern Ireland — with full access to both the EU-27 and the UK via the NI Protocol.
For commercial and industrial energy users: ESOS compliance, UK Energy Regulations 2024, energy performance improvement, and ISO 50001 support.
Available as a standalone service.
Your company is outside the UK. You sell or intend to sell medical devices/IVDs in Great Britain (England, Scotland, Wales).
Registered with: MHRA
Your company is outside the EU. You CE-mark medical devices/IVDs for sale in any EU member state.
Some manufacturers need both — for example, a US or Asian manufacturer placing products on both GB and EU markets. We can handle both appointments, structured correctly through the appropriate entity.
Send an enquiry or — if you already know what you need — complete the letter of appointment directly.
Our partners often bring clients straight to appointment stage. No lengthy discovery process required.
We agree the mandate and service terms.
We prepare the regulatory documentation, MHRA or EUDAMED registrations, and any device-specific submissions required.
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.
We hold working knowledge of the regulatory frameworks, standards, and operational environments we service — built over more than three decades of direct engagement across the UK, EU-27, and international markets.
UKRP and EU-REP services for medical device and IVD manufacturers placing products on the UK and EU markets.
Ongoing regulatory liason
Within the European database for medical devices. Available as a standalone service or integrated within a wider regulatory programme.
Testing, inspection, and certification activities covering machinery, pressure equipment, and product conformity.
Multi-standard audit programmes delivered on-site or remotely by experienced auditors with direct industry backgrounds.
End-to-end compliance support for medical device and in vitro diagnostic manufacturers across the EU Medical Device Regulation (2017/745) and IVDR (2017/746).
Across industrial, manufacturing, and infrastructure environments.
Our approach is evidence-led, structured & designed for real-world application — not theory.
Medical device manufacturers, IVD producers, pharmaceutical groups, NHS and private healthcare providers, sterile processing and laboratory environments.
Complex manufacturers, precision engineering, calibration and testing facilities, production and QC environments, logistics and warehousing operations.
Offshore and subsurface operators, mechanical and electrical systems, pressure equipment environments, energy management and efficiency programmes.
Contractors and principal designers with machinery conformity, pressure testing, and occupational health and safety obligations.
Law firms, professional services organisations, and regulated advisors requiring information security, ISO 27001 support, or third-party audit services.
Businesses across sectors needing management system certification support, supplier auditing, or regulatory compliance frameworks without in-house capability.
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.
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.
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.
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.
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.
Contact us to describe your situation. We will confirm scope, timeline, and cost before any engagement begins.
