Our primary services are UK Responsible Person (UKRP) and EU Authorised Representative (EC-REP) appointments for medical device and IVD manufacturers. Select a service below, or use the filter to find what you need.
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.
Our role
We are registered with the MHRA and act as your UKRP — managing device registration, vigilance reporting, and regulatory correspondence on your behalf.
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.
Our role
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.
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.
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.
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.
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.
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.
