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Medical Devices & IVDs

Our primary sector. We act as UK Responsible Person and EU Authorised Representative for device and IVD manufacturers entering or operating in the UK and EU markets — managing MHRA registration, EUDAMED data, and ongoing regulatory obligations.
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All sectors
  • UK and EU-27 markets
Sector Overview

Our offering for the Medical Devices & IVDs sector

Our primary area of activity. We work with medical device and IVD manufacturers at every stage of market entry and ongoing regulatory compliance — from initial UKRP or EC-REP appointment through to MHRA registration, EUDAMED management, and post-market surveillance support.

Manufacturers in this sector face a regulatory environment that continues to evolve. MDR and IVDR transition timelines, EUDAMED obligations, and MHRA post-Brexit requirements all require active management — not a one-time submission. We provide that ongoing management as a registered representative, not as an advisor standing at a distance.

Regulatory context:

  • EU MDR (2017/745)
  • EU IVDR (2017/746)
  • UK MDR 2002 (as amended)
  • MHRA registration requirements
  • MDSAP programme
  • ISO 13485
  • ISO 14971
  • IEC 62304 (SaMD)
  • EUDAMED obligations
  • MDR/IVDR transition timelines
  • NI Protocol (Windsor Framework)
Typical clients

Who we work with

  • Medical device manufacturers (Class I–III)
  • IVD manufacturers
  • Contract manufacturers
  • Combination product developers
  • Companies transitioning legacy devices to MDR/IVDR timelines
  • UK manufacturers post-Brexit needing an EC-REP
Related services

Our Medical Devices & IVDs services

Core Service

UK Responsible Person

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

EU Authorised Representative

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.
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.
Appoint us as your EC-REP
Core Service

MHRA Registration

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

EUDAMED Registration

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

Ready to get compliant?

Whether you’re preparing for UK or European medical markets, in need of any of our other services, or you’re not sure what you need yet… please do get in touch.

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