UKCA Marking
The UK's post-Brexit conformity mark for the Great Britain market, overseen by the MHRA.
Overview
What UKCA is and why it matters
UKCA (UK Conformity Assessed) marking is required to place most medical devices on the Great Britain market. The UK government has adjusted the CE-to-UKCA transition timeline more than once since Brexit — manufacturers should confirm the current transition deadline directly with the MHRA before assuming CE Marking alone remains sufficient for GB.
Requirements
What you'll need
- Device classification aligned to UK MDR 2002 (as amended)
- UK Approved Body conformity assessment (Class IIa and above)
- UK Responsible Person appointed (non-UK manufacturers)
- Technical documentation
- MHRA device registration
- Confirm current CE-recognition transition deadline with MHRA before relying on CE Marking alone for GB
Typical timeline
6–18 months
Broadly mirrors CE Marking timelines; UK Approved Body capacity is a current constraint.
Estimated cost
$15k–$120k
Comparable to CE Marking costs for an equivalent device class.
Where this applies
Applicable countries
Related
Regulatory Pathways
FAQ
Frequently asked questions
Is CE Marking still accepted in Great Britain?+
The UK has extended recognition of CE Marking for GB more than once since Brexit — the current deadline should always be confirmed directly with the MHRA rather than assumed from past guidance.
Does UKCA apply in Northern Ireland?+
Northern Ireland follows a different arrangement under the Windsor Framework — this page covers Great Britain (England, Scotland, Wales) only.
Related
Related Certifications
Reviewed launch planning
Ready to start your UKCA project?
GHMAP structures your certification path, evidence gaps, and next actions — then connects you with a qualified consultant if you need one.
Professional review remains part of the workflow.