UKCA marking & UKNI marking
Access to the UK market and post-Brexit regulation
Why is UKCA marking essential for marketing in the UK?
- Understand and apply the requirements of UKCA marking and UKNI.
- Ensure product compliance with UK regulations.
- Identify the Notified Bodies responsible for conformity assessment.
- Ensure the transition from CE marking to UKCA and UKNI.
- Facilitate access to markets in Great Britain and Northern Ireland.
Post-Brexit regulatory context
Which products are covered by UKCA marking?
What are the differences between CE marking, UKCA marking and UKNI marking?
| Marking | Zones concerned | Recognition |
|---|---|---|
| European Union, Northern Ireland Valid in the United Kingdom until further notice | ||
| UKCA | Great Britain (England, Wales, Scotland) | Not valid in the EU |
| Valid only with CE marking |
How to obtain UKCA marking
Conformity assessment procedure
- Determine whether the product falls under a regulation requiring UKCA certification.
- Check whether self-certification is possible or whether a third-party body is required.
Testing and certification
- Tests carried out by a UK Approved Body.
- Verification of essential requirements equivalent to European standards.
Documentation and marking
- Drawing up of the UKCA Declaration of Conformity, indicating the standards applied and the manufacturer's responsibilities.
- Permanent affixing of the UKCA marking from January 2025.
- Retention of technical documents for 10 years after the product is placed on the market.
UKNI marking for Northern Ireland
- Northern Ireland remains aligned with EU regulations, which means that :
- CE marking is still required** to sell products in Northern Ireland.
- If a product is certified by a UK Notified Body, it must carry UKNI marking in addition to the CE marking.
- A product bearing the CE + UKNI marking cannot be sold in the EU.
Talk to our experts in CE marking, UKCA and UKNI
Specific requirements and exceptions
The UKCA marking does not apply to the following products, which remain governed by other regulations:
- Medical devices
- Construction products
- Railway products
- Marine equipment
- Unmanned aircraft systems
- Specific rules for these categories will be clarified by the UK government.
The special case of medical devices
As with other equipment, UKCA marking has been in force since 1 January 2021 for Great Britain, and CE marking (with the possible addition of UKNI) remains in force for Northern Ireland. The UK medical device market is regulated by the MHRA (Medicines and Healthcare products Regulatory Agency).
Following Brexit, UK regulations are gradually moving away from European standards, which has led to the introduction of UKCA marking for medical devices (MDs).
The July 2024 deadline marked a key milestone in the replacement of CE marking with UKCA marking in Great Britain (England, Scotland, Wales). Manufacturers had to start adapting to this change to avoid any market disruption.
However, in 2023, the UK government decided to extend the transition periods for the use of CE marking in Great Britain to give businesses more time to adapt. This extension varies depending on the type of product, and for MDs, the transition period can last until 30 June 2026.
MDs that already bear the CE marking can therefore continue to be marketed in Great Britain until that date.
Why choose the expertise of the Emitech Group?
- Understanding applicable regulations and certification requirements.
- Setting up an appropriate compliance process to avoid administrative bottlenecks.
- Manage the transition to UKCA marking or UKNI to ensure continuity of sales in the UK.
- Optimise technical documentation and declarations of conformity
Related Services
Needs
Discover a selection of additional resources that explore topics related to this page including regulatory contexts, technical articles, and specific areas of expertise. These materials provide further insight to help you better understand the key challenges and available solutions.
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