Guide

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.

Healthcare & Social Care UK-wide

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.

Placing medical devices on the Northern Ireland market

How to comply with the Northern Ireland medical device regime under the Windsor Framework. Covers EU MDR/IVDR requirements, CE marking, UKNI marking via UK Approved Bodies, EU Authorised Representative, and dual compliance for manufacturers selling in both GB and NI.

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Classify your medical device for the GB market

How to classify your medical device under the UK Medical Devices Regulations 2002. Covers Class I through III for general devices, active implantable devices, IVDs (current Annex system and future Class A-D), and Software as a Medical Device.

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Choosing a UK Approved Body for medical devices

How to select and engage a UK Approved Body for conformity assessment of your medical device. Covers the 7 designated bodies and their scope, when an Approved Body is required, the assessment process by device class, and when self-certification is permitted.

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