Place your device on the Great Britain market with the right marking and registration.
CE or UKCA routes, UK Responsible Person coordination and MHRA registration, with the post-market requirements that now apply in Great Britain.
Key facts
Pathways
- CE-marked devices accepted in Great Britain under transitional arrangements, with end dates that depend on the legislation the device meets
- UKCA marking through a UK Approved Body, or self-declaration for Class I and general IVDs
- Registration with the MHRA before placing devices on the GB market
- Northern Ireland follows the EU MDR and IVDR
What you will need
- Technical documentation and declaration of conformity
- Certificates from an EU Notified Body or UK Approved Body as applicable
- UK Responsible Person details on labelling where required
- Registration information for the MHRA
Sequence and decision points
- 01Choose the routeCE reliance under transitional arrangements, or UKCA marking.
- 02Appoint a UK Responsible PersonRequired for manufacturers based outside the UK.
- 03Conformity assessmentUK Approved Body assessment where the class requires it.
- 04Register with the MHRADevices registered before they are placed on the market.
- 05MonitorVigilance reporting and GB post-market surveillance.
ISO 13485 is the designated standard. Approved Body or Notified Body QMS assessment applies above Class I and general IVDs.
Manufacturers outside the UK must appoint a UK Responsible Person for Great Britain.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
MHRA registration fees are published by the MHRA, and Approved Body timelines vary. Transitional dates for CE-marked devices differ by device type and legislation; confirm them against current MHRA guidance.
After market entry
- Vigilance and field safety reporting to the MHRA
- GB post-market surveillance requirements, in force since 16 June 2025
- Registration updates when devices or details change
How we help
- GB route strategy: CE reliance or UKCA
- UK Responsible Person coordination
- MHRA registration support
- UKCA technical documentation
- GB post-market surveillance and vigilance
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about United Kingdom
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can we keep selling CE-marked devices in Great Britain?
Yes, for now, under transitional arrangements. The end dates depend on whether the device meets the MDD, IVDD, MDR or IVDR, so plan your longer-term route early.
What applies in Northern Ireland?
Northern Ireland follows the EU MDR and IVDR.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.