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Using the UK Conformity Assessed (UKCA) Mark

Are you ready to use the UKCA mark after Brexit? A conformity mark must be used when placing certain products on the UK market. 

Before 1 January 2021, you can do this using the CE mark or other appropriate mark.

From 1 January 2021, the UKCA (UK Conformity Assessed) mark will be the conformity assessment marking for Great Britain for most goods currently subject to CE marking.

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

The UKCA marking is a new UK product mark that will be used for goods placed on the market in Great Britain (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 1 January 2021 depends on the type of product. The new UKCA rules are clear for products currently certified under the EMC, Low Voltage, Radio Equipment, or ATEX directives. There are different rules for:

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

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.

When will it be introduced? 

The UKCA marking can be used from 1 January 2021. While the UKCA marking has no legal meaning if placed on any product before this date, you are encouraged to be ready to use it in advance. 

To allow businesses time to adjust to the new requirements, there will be a transition period up until 1 January 2022, during which you will be able to continue to use the CE mark in Great Britain. There is no reciprocal transition for the EU.

From 1 January 2021, if you apply the UKCA marking, then you must meet all of the requirements of the UKCA regulations.

After 1 January 2021, you must use the new UKCA marking immediately if all of the following apply:

  • The product is covered by legislation which requires the UKCA marking   
  • The product requires 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 1 January 2021

This does not apply to pre-existing stock that has been fully manufactured and conformity marked before 31 December 2020. This stock can still be placed on the GB market after 1 January 2021 with existing markings and notified body numbers.

Up until 1 January 2022, 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 1 January 2022, UKCA marking will replace all CE marking in Great Britain. 

After 1 January 2021, you may choose to use the UKCA marking after Brexit, even if the transition arrangements would apply, for example, where your customer insists on the new mark. 

There is no transition arrangement for products certified by UK Notified Bodies. To continue to be sold in the EU-27 after 1 January 2021, the certificates must be transferred to an EU-27 recognized Notified Body. Element’s Notified Bodies outside of the UK are able to 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. 

From 1 January 2021, 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 to the technical requirements necessary for CE marking, then it will be compliant to the same technical requirements that will exist for UKCA marking from 1 January 2021. However, the conformity assessment bodies that assess them may be different, although, in the case of Element, 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 2020 will require UKCA marking, and any products that currently need approval by a Notified Body will have to be certified by a 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. 

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 a UK Approved Body to be legally sold in Northern Ireland (but not the rest of the EU). This is shown on the product by use of the special UK(NI) marking adjacent to the CE mark.

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?

Manufacturer’s legal obligations will remain largely unchanged from 1 January 2021. However, if you are bringing goods from outside the UK and placing them on the market in Great Britain, you will now be an ‘importer’ and carry more compliance responsibilities, including ensuring that the product has an adequate technical file. UK distributors and suppliers, therefore, will need to establish whether they will become an importer after 1 January 2021.

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 labeling requirements
  • Products are labeled with your company’s details, including your company’s name and a contact address (in this case of the UKCA, until 31 December 2022, 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 declaration of conformity is maintained for a period of 10 years
  • Products conform with the relevant essential requirements

Authorized representatives and responsible persons based in the EU will no longer be recognized in Great Britain from 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 Element about precisely how the conformity processes for your product will be affected. You may need to take additional action if the product needs third-party conformity assessment, such as a Notified Body Type Examination or factory audit.

From 1 January 2021, EU appointed Notified Bodies based in the UK will be referred to as UK Approved Bodies. The CE marking will no longer be valid or accepted by EU authorities after 31 December 2020 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 EU).

Our team of experts can help you continue to export to the EU without needing to find a new EU notified Body. All Element UK Notified Body certificates will be transferred to another Element 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. 

The transferring of all certificates, either EU to UK or UK to EU, needs to take place before 31 December 2020. After this date, a new submission for certification will need to be made.

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.

 

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