Healthcare & Social Care Product compliance and marking

UKCA and CE marking for medical devices

How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA marking via UK Approved Bodies, CE marking transitional acceptance (2028/2030 deadlines), the MHRA consultation on indefinite CE recognition, dual marking for GB and NI access, and NI-specific requirements.

UK-wide
Guide summary

You must choose between UKCA or CE marking for medical devices sold in Great Britain. UKCA is permanent, CE is temporary until 2028 or 2030. Northern Ireland requires CE marking. Check if your device needs UK Approved Body certification.

  • Use UKCA marking for permanent GB market access
  • CE marking accepted until 30 June 2028 (or 2030 for some devices)
  • Northern Ireland requires CE marking only
  • Class IIa, IIb, III devices need UK Approved Body certification
  • Class I devices can be self-certified by the manufacturer
  • Dual marking (UKCA and CE) is allowed
  • MHRA may extend CE acceptance beyond 2028/2030
  • 7 UK Approved Bodies available for certification
  • Check device class and intended use before choosing a body
  • Monitor MHRA consultation results on indefinite CE recognition
On this page
UK-wide

Related guides in International Trade

Medical devices have separate marking rules from most other products. The indefinite CE marking recognition that applies to 21 product regulations does not extend to medical devices. Instead, MHRA operates its own transition timelines.

You have two options for placing a medical device on the Great Britain market (England, Scotland, Wales):

  • UKCA marking via a UK Approved Body — permanent, no expiry date on the GB market
  • CE marking — accepted during the transitional period (see deadlines below)

Choosing your marking route

Choose UKCA marking if:

  • You want permanent GB market access with no deadline risk
  • You are a UK-based manufacturer
  • You only sell on the GB market (not NI or EU)
  • You want to avoid dependency on EU Notified Body capacity

Choose CE marking (transitional) if:

  • You already hold a valid CE certificate from an EU Notified Body
  • You sell in both GB and EU markets and want a single certificate
  • Your CE certificate will not expire before 30 June 2028 (or 2030 for EU MDR/IVDR certificates)
  • You are awaiting the outcome of the MHRA consultation on indefinite CE recognition

MHRA consultation: MHRA launched a consultation on 16 February 2026 (closing 10 April 2026) proposing indefinite recognition of CE marked medical devices on the GB market, which would remove the 2028/2030 deadlines entirely. Monitor GOV.UK for the outcome.

Dual marking for GB and NI

If you sell medical devices in both Great Britain and Northern Ireland, you need to comply with two different regulatory frameworks. Products can carry both UKCA and CE marks simultaneously. The most common approaches are:

  • CE mark from EU Notified Body: Valid for both NI (permanently) and GB (until transition deadlines). Simplest single route for dual access.
  • CE + UKNI mark from UK Approved Body: Valid for NI market. The UKNI marking must accompany the CE mark when a UK Approved Body has conducted the conformity assessment.
  • UKCA mark (UK Approved Body) + CE mark (EU Notified Body): Two separate conformity assessments. UKCA for permanent GB access, CE for NI and EU access.

Marking guidance