Manufacturing & Engineering Product compliance and marking UK-wide

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.

Guide summary

Choose between UKCA and CE marking for your medical device. UKCA marking gives permanent access to the Great Britain market. CE marking is accepted until 30 June 2028 for medical devices and until 30 June 2030 for in vitro diagnostics. In Northern Ireland, you must use CE marking only.

  • Use UKCA marking for permanent GB market access
  • CE marking accepted until 30 June 2028 for medical devices
  • CE marking accepted until 30 June 2030 for IVDs
  • In Northern Ireland, CE marking is mandatory
  • Products can carry both UKCA and CE marks together
  • Check MHRA consultation on indefinite CE recognition by 10 April 2026
  • Class I devices can self-certify without a UK Approved Body
  • Class IIa, IIb, III need a UK Approved Body for UKCA marking
  • 9 UK Approved Bodies are designated for medical devices
  • If your CE certificate expires before the deadline, UKCA becomes mandatory
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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