United Kingdom (MHRA)

Liverpool waterfront with the Royal Liver Building and the Three Graces

The UK government confirmed in October 2026 that CE-marked medical devices will continue to be accepted in Great Britain on a long-term basis, while UKCA remains the domestic route. We make sure your O&P, foot health and rehabilitation products are registered and represented correctly.

How we help

  • MHRA device registration
  • UK Responsible Person services for manufacturers based outside the UK
  • UKCA conformity assessment where you need it
  • ISO 13485 quality systems
  • Post-market surveillance and vigilance under the strengthened UK requirements
  • Product safety compliance for non-medical products

Delivered by Deliberate

We took over a UK ISO 13485 project that had cost $300,000 over 12 months without certification, and achieved certification within six months for $30,000.

Talk to us about the UK

Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.

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