UKCA mark: where are we now?

It is therefore important to understand not only the current guidelines to the UKCA implementation, but how the easement changes might apply to you, including how and when you will be legally obliged to use it for goods placed on the market in Great Britain.

Simon Barrowcliff, Senior Technical Specialist at Element Materials Technology further explores.

Overview of the UKCA regime

The UKCA mark is for goods being placed on the market in Great Britain. This means England, Wales, and Scotland must all follow UKCA marking as their prime conformity assessment set of rules. Northern Ireland does not use the UKCA mark and still follows CE marking rules, like the 27 countries in the EU, because of the Northern Ireland Protocol. A UK Approved Body can still certify a product for use in Northern Ireland using the CE rules, and under these circumstances the manufacturer applies the UKNI logo immediately after their CE mark.

To summarise, we now have:

• the UKCA mark in Great Britain
• the CE mark in Europe
• the CE mark in Northern Ireland where a third party (UK Approved Body) isn't involved
• the CE UKNI if a UK Approved Body has done the conformity assessment for Northern Ireland

The UKCA mark is intended to cover most products that previously required CE marking and was designed to emulate the previous CE regulations. This means that whilst technically the changes should not significantly impact manufacturers, there are a number of administrative changes.

Administrative changes which manufacturers need to know

Administrative changes which you should be aware of include changes to:

• markings on the product
• documentation supplied with the product
• importer details
• the declaration of conformity; the GB market now requires a UK declaration of conformity
• the way you are represented within the GB market
• how the regulations are enforced in Great Britain and Northern Ireland

Whilst there are exceptions, the same general rules apply to most products sitting under the authority of the UK Government department of Business, Energy and Industrial Strategy (BEIS). These relate principally to CE marking under EU Product Directives such as EMC, Low Voltage, Radio Equipment, ATEX and Machinery. In November 2022, BEIS delayed the mandatory implementation of the UKCA regulations for a further two years from January 1, 2023 to January 1, 2025. UKCA can be used on a voluntary basis immediately.

Different rules apply for other UKCA regulations which cover specific product categories such as:

• medical devices
• rail interoperability
• construction products
• civil explosives
• marine equipment
• cableways
• energy using products
• transportable pressure equipment
• hazardous substances (RoHS)

The Medicines and Healthcare Products Regulatory Agency, for example, has produced its own guidance on the regulations for medical devices, with the crossover period extended to June 30, 2024. For construction products, guidance to the different rules is available from the department for Levelling up, Housing and Communities (DLUHC) and the transition period has been extended to December 31, 2024. For more information on how these special rules apply, click here.   

Summary of easement changes from BEIS

1. The delay to implementation means that you can continue to use CE marking as evidence of conformity assessment for the GB market and the Northern Ireland market until January 1, 2025
2. UKCA marking and importer details for goods from EEA countries will continue to be allowed and can be placed via a sticky label or on an accompanying document until December 31, 2027
3. Spares entering the GB market will continue to be accepted to repair, replace and maintain products to the same conformity requirements in place at the time the original product or system was placed on the GB market
4. There is no need to retest and remark existing imported stock that has been CE marked and has been brought into the UK before December 31, 2024
5. A relaxation in terms of reduced retesting costs by allowing some third-party certificates provided by EU Notified Bodies to be used in support of UKCA marking after January 1, 2025 until December 31, 2027

Changes to UKCA marking and importer details

The regulations state that the UKCA marking and importer details must be permanently fixed to the product. However, the easement allows manufacturers to alternatively apply the UKCA marking on a sticky label to the product or with an accompanying document until December 31, 2027.

This also applies to importer details which can alternatively be affixed on to the product via a sticky label or on an accompanying document until December 31, 2027.

The accompanying document must stay with the product until it reaches the end user. This requires it being included in the product’s final packaging, such as in the instructions manual, or an addendum to the instructions.

Spares and replacement parts

You are now allowed to continue with the supply and use of spare parts for products that are already in the UK and were CE marked prior to December 31, 2024 to allow you to continue to provide spare parts for those products under the Regulations that were in force as of the end of December 2024.

This means CE Marked spare parts for those specific products are permitted to be used. However, you are going to need documentary evidence to demonstrate that the spare part is for a product that was imported or CE marked prior to December 31, 2024. This may require you putting a document system in place to show why your non-UKCA marked spare parts are acceptable if you want to take advantage of the relaxation regarding spare parts.

The use of existing EU Notified Body certification  

Third-party certificates provided by EU Notified Bodies can be used in support of UKCA marking after January 1, 2025 until December 31, 2027.This applies where a third-party UK Approved Body is required by the original UKCA regime which means it isn’t relevant for directives like the Low Voltage Directive or the electrical equipment regulations, but it is relevant for EMC and radio equipment, the Machinery Directive, the ATEX Directive and their associated regulations, where there is notified body involvement either in factory production control or for testing of the product. In these situations, the notified body for the EU is replaced by a UK Approved Body before you can apply the UKCA mark.

The easement means that certificates issued to equivalent EU directives by an EU Notified Body before the end of 2024 can now be used as the basis for UKCA marking certification without the intervention of a UK Approved Body until the end of 2027. Therefore, if you have a current EU Notified Body certificate, you can continue to apply the UKCA mark without involving a UK Approved Body. However, you will need to undergo a conformity assessment with a UK Approved Body at the expiry of the product or factory certificate, or after three years, whichever is the sooner.

Any amendment or re-issue to an EU Notified Body certificate used as the basis of UKCA marking will trigger the involvement of a UK Approved Body. As a result, you should ensure that you start using an approved body as soon as you do anything significant to the product.

Should you wait or is it time to UKCA mark your product now?

A frequently asked question regarding the easement changes is if a manufacturer chooses to wait to apply UKCA, will it make the product compliance look out of date? Manufacturers will have to weigh up this issue and decide for themselves. If the UKCA mark is already becoming prevalent amongst competitive products and they choose not to apply it, it may not be worth taking the risk of looking outdated when you consider that you will have to do it at some point soon as the UKCA is scheduled to be fully enforced by December 31, 2027.

Whilst there may be further government updates as policy evolves, the UKCA mark is eventually going to fully replace the CE mark and preparing sooner rather than later is probably the best course of action for most manufacturers.