ÌìÃÀ´«Ã½

Are you ready to use the UKCA mark after Brexit? Are your EMC, Low Voltage, Radio Equipment, or ATEX products compliant with this? A conformity mark must be used when placing certain products on the UK market. 

Before 31 December 2024, you can do this using the CE mark or other appropriate marks. From 31 December 2024, the UKCA (UK Conformity Assessed) mark may be the conformity assessment marking for Great Britain for most goods currently subject to CE marking.

However, for some UK regulations the CE mark may still be permitted beyond 2024. On 1 August 2023, the government announced its intention to extend recognition of the CE marking, indefinitely, beyond the original UKCA implementation date of 31 December 2024. These updates apply to the 18 regulations that fall under the Department for Business and Trade (DBT). The government has stated that revised legislation for each of these regulations will be published late in 2024.

The 18 DBT regulations are:

• toys
• pyrotechnics
• recreational craft and personal watercraft
• simple pressure vessels
• electromagnetic compatibility
• ·non-automatic weighing instruments
• measuring instruments
• measuring container bottles
• lifts
• equipment for potentially explosive atmospheres (ATEX)
• radio equipment
• pressure equipment
• personal protective equipment (PPE)
• gas appliances
• machinery
• equipment for use outdoors
• aerosols
• low voltage electrical equipment

What is the UKCA mark, and where is it going to be used?

The UKCA regulatory regime will apply regardless of any Free Trade Agreement (FTA) between the UK and EU. Although the UK is seeking a Mutual Recognition Agreement for conformity assessment in the UK-EU FTA, this is currently refused by the EU. Companies whose products require mandatory third-party testing by a Notified Body should review whether that Body is located in the UK or EU and whether it has arranged to have certification validated or re-issued by a partner test body in the other market.

The UKCA marking is a new UK product mark used for goods placed on Great Britain's market (England, Wales, and Scotland). The marking covers most products that previously required CE marking. It will not be used for products placed on the Northern Ireland market, which require CE marking or UK(NI) marking. Products currently requiring a CE marking for sale in the EU will continue to need a CE mark. 

What you will need to do from 31 December 2024 depends on the type of product.. There are different rules for:

• Products regulated under the old approach, in particular: chemicals, medicines, vehicles, and aerospace
• Products covered by national regulations (non-harmonized)
• Certain other products, such as medical devices, civil explosives, construction products, and rail interoperability

When will it be introduced? 

The UKCA marking has been available for use since 1 January 2021. Given the difficult economic conditions created by post-pandemic shifts in demand and supply, alongside Putin’s war in Ukraine and the associated high energy prices, the government does not want to burden business with the requirement to meet the original (31 December 2022) deadline.

The government will continue to recognise the CE marking for 2 years, therefore allowing businesses until 31 December 2024 to prepare for the UKCA marking. Businesses can also use the UKCA marking, giving them flexibility to choose which marking to apply.

After 31 December 2024, you must use the new UKCA marking immediately if it is not one of the 18 DBT regulations and when all the following apply:

• The product is covered by UK legislation that requires the UKCA marking
• The product requires a mandatory third-party conformity assessment

• A conformity assessment has been carried out by a UK-based Notified Body and you haven’t transferred your conformity assessment files from your UK body to an EU-27 recognized Notified Body before 31 December 2024

Up until 31 December 2024, under the transition arrangements, you will be able to continue to use the CE marking in the United Kingdom if:

• You currently apply the CE marking to your product on the basis of self-declaration
• A mandatory third-party conformity assessment was carried out by an EU-27 recognized Notified Body
• The EU-Type Examination certificate previously held by a UK Notified Body has been transferred to an EU-27 recognized Notified Body

It is important to note that you can only place CE-marked goods that meet EU requirements in Great Britain while the UK and EU requirements remain the same. If the EU changes its rules and you CE mark your goods based on those new EU rules, you will no longer be able to use the CE marking in the UK. 

After 31 December 2024, UKCA marking will replace all CE marking in Great Britain 9ecept for the 18 regulations controlled by the DBT. 

There was no transition arrangement for products certified by UK Notified Bodies. To continue to be sold in the EU-27, the certificates must have been transferred to an EU-27 recognized Notified Body. ÌìÃÀ´«Ã½’s Notified Bodies outside of the UK can support this.

Using both the CE and UKCA mark after Brexit

Products can carry both the CE and UKCA markings so long as they are fully compliant with both EU directives and UK regulations. 

The standards that can be used to demonstrate conformity with the technical or ‘essential’ requirements for UKCA-marked products will be the same as they are now under CE marking. That means that if your product is currently compliant with the technical requirements necessary for CE marking, then it will be compliant with the same technical requirements that will exist for UKCA marking. However, the conformity assessment bodies that assess them may be different, although, in the case of ÌìÃÀ´«Ã½, we can support both sets of requirements because we hold both UK Approved Body and EU recognized Notified Body status.

Products placed on the UK market after 31 December 2024 may require UKCA marking, and any products that currently need approval by a Notified Body may need to be certified by the UK Approved Body. Notified Body and Approved Body certificates operate under separate accreditations and legal jurisdictions. Hence different certificate numbers will apply in addition to any product marking associated with the Body. The UK Approved Body number (4 digits) must follow the UKCA mark on the product where third-party conformity assessment is required.

A single test report and/or the technical file can be used for both the UKCA and CE marking requirements, allowing testing to be carried out simultaneously and preventing additional testing costs.  An accredited UK test report remains valid for both CE marking and UKCA making.

A separate Declaration of Conformity is needed for both CE Marking and UKCA, so manufacturers need to be aware that additional paperwork is required. The UK Declaration of Conformity must reference the UK Regulations and the UK British Standard versions of EN standards, where they exist.

What about products for sale in Northern Ireland?

Northern Ireland will remain subject to EU CE marking regulations. Any CE-marked product can be sold in Northern Ireland. The Northern Ireland Protocol allows products certified to EU directives in Great Britain by the UK Approved Body to be legally sold in Northern Ireland (but not the rest of the EU). This is shown on the product by using the special UK(NI) marking adjacent to the CE mark. The UKNI mark is only applied under the authority of a UK Approved Body and should not be applied by manufacturers without explicit permission to do so.

Products for sale in both Great Britain and the EU that carry both CE marking and UKCA marking do not need the additional UK(NI) mark.

Will my legal responsibilities also be changing?

The manufacturer’s legal obligations remain largely unchanged. However, suppose you are bringing goods from outside the UK and placing them on the market in Great Britain. In this case, you will now be an ‘importer’ and carry more compliance responsibilities, including ensuring that the product has an adequate technical file. Therefore, UK distributors and suppliers need to establish if they’re an importer.

Anyone based in the EU, bringing in UK products to place on the EU market, will also become an importer and bear more responsibility for compliance. 

Importers will need to make sure:

• The manufacturer has drawn up the correct technical documentation and complied with their labelling requirements
• Products are labelled with your company’s details, including your company’s name and a contact address (in this case of the UKCA, until 31 December 2024, you can provide these details on the accompanying documentation rather than on the product itself)
• The correct conformity assessment procedures have been carried out, and products have the correct conformity markings
• A copy of the UK declaration of conformity is maintained for 10 years
• Products conform to the relevant essential requirements

Authorized representatives and responsible persons based in the EU are no longer recognized in Great Britain since 1 January 2021. If you plan to use an authorized representative or responsible person, they will need to be based in the UK for products being placed on the GB market.

What should I be doing now to prepare? 

Now is the time to speak to ÌìÃÀ´«Ã½ about precisely how your product's conformity processes will be affected. You may need to take additional action if the product needs a third-party conformity assessment, such as a Notified Body Type Examination or factory audit.

Since 1 January 2021, EU-appointed Notified Bodies based in the UK are referred to as UK Approved Bodies. The CE marking is no longer valid or accepted by EU authorities for any product which was CE approved using a UK-based former EU Notified Body.  Instead, the certification needs to be transferred to an EU-27 Notified Body to be maintained or a Notified Body recognized by the EU (such as those countries that have an MRA with the EU).

Our team of experts can help you continue to export to the EU without needing to find a new EU-notified Body. All ÌìÃÀ´«Ã½ UK Notified Body certificates will be transferred to another ÌìÃÀ´«Ã½ Notified Body (within or recognized by the EU-27).

If the certificate needs to be transferred from an EU Notified Body to the UK Approved Body, the product will also require UKCA marking for the UK market, including a technical file and UK Declaration of Conformity by 31 December 2024.

Conformity assessment activities for CE marking undertaken by 31 December 2024 can be used as the basis for the UKCA marking, until 31 December 2027.

For advice on using the UKCA Mark after Brexit or CE Marking a device and ensuring your responsibilities have been adequately met, please contact Element here.