UKCA Certification

The UK government has announced the launch of a new conformity mark, UKCA (representing those who have obtained UK conformity assessment). Specific products such as automobiles, aerospace, pharmaceutical products, medical devices, chemicals, and items regulated by national regulations (non coordinated items) will no longer be able to use EU regulations and conformity marks when sold in the UK market after Brexit.

The UKCA logo in the UK is about to take effect, please refer to the detailed guidelines here!

On September 1, 2020, the UK Department for Business, Energy and Industrial Strategy issued guidelines on the use of the UKCA logo. Starting from January 1, 2021, the UKCA logo will be used on products marketed in the Great Britain region (GB) of the United Kingdom, which includes England, Wales, and Scotland but does not include Northern Ireland; But in order to give the market more time to adapt to the new requirements, the CE mark on most products can still be accepted before January 1, 2022.

The relationship between UKCA mark and CE mark

The UKCA mark will come into effect on January 1, 2021, but in order to give businesses time to adapt to the new requirements, the UK market (Great Britain region) will accept the CE mark for products before January 1, 2022. For products that have been fully manufactured and ready for market before January 1, 2021, they can still be sold in the UK market (Great Britain region) using the CE mark until January 1, 2022.

Products currently being sold to the UK market (Great Britain region) and newly designed products that have not yet been launched are required to use the UKCA logo from January 1, 2021.

In order for the same new product to enter the EU market, it is also necessary to obtain the CE mark. The EU authorities will not accept the UKCA logo. Starting from January 1, 2022, the UKCA mark will be a mandatory mark for entering the UK market (Great Britain region) (with exceptions for products subject to special transition deadlines).

Currently, products entering Northern Ireland will continue to use the CE mark or UK (NI) mark according to special treatment agreements. It is expected that Northern Ireland will make new adjustments after the 2024 referendum.

The relationship between UK regulations and EU directives

At present, the EU directives corresponding to UK regulations are shown in the table. The requirements of UK regulations for product scope, standards, conformity assessment procedures, etc. are basically consistent with EU directives. However, relevant regulations in the UK will be updated periodically, such as the "2019 Energy Related Product Eco Design and Energy Information (Revised) Regulation" with reference number 8, which has modified relevant terms and expressions, added transitional clauses for exiting the EU, etc., in preparation for the use of the UKCA logo.

Scope of application of UKCA logo

The UKCA mark will cover most products currently regulated by the CE mark as well as aerosol products.

Rules for the Use of UKCA Logo

1. Add UKCA logo

Before January 1, 2023, for most products (excluding those subject to special rules), the UKCA logo can be affixed to the product label or accompanying documents. Starting from January 1, 2023, in most cases, the UKCA logo must be directly affixed to products. Therefore, companies should start preparing for this.

The following are general rules:

The UKCA logo can only be affixed to products by the manufacturer or their authorized representative in the UK (where permitted by law)

When affixing the UKCA logo, the manufacturer assumes full responsibility for whether the product complies with relevant regulatory requirements

Only the UKCA logo can be used to prove that the product complies with relevant UK laws

◆ Do not provide any signs or marks that may misunderstand the meaning or form of the UKCA logo to third parties

◆ No other markings that affect the visibility, readability, or meaning of the UKCA logo shall be affixed to the product

Unless explicitly required by law, the UKCA logo shall not be affixed to products

2. Rules for using UKCA logo

Manufacturers must ensure that:

If the size of the logo is reduced or expanded, the relevant proportions of the UKCA logo letters must be followed

The height of the UKCA logo should be at least 5 millimeters, unless different minimum sizes are specified in relevant regulations

The UKCA logo must be clearly visible

Five technical document requirements

1. Record keeping

Manufacturers or their authorized representatives (where permitted by law) must keep documents proving that the product complies with regulatory requirements. After the product is launched on the market, it must be kept for 10 years.

The retained files will depend on specific regulations related to the product, but general records of the following must be kept:

How to design and manufacture products

How to prove that the product meets the relevant requirements

◆ Manufacturer's and any storage facility's address

The UK market supervision or enforcement agencies may request this information at any time to check whether the product meets legal requirements.

2. Declaration of Conformity (UK DoC)

The UK DoC is a document that must be drafted for most compliant products bearing the UKCA logo.

In the document, the manufacturer or its authorized representative in the UK (where permitted by law) shall:

Declaration that the product complies with the relevant legal requirements applicable to a specific product

◆ Ensure that the document contains the name and address of the manufacturer (or authorized representative in the UK), as well as information about the product and the conformity assessment agency (if relevant)

Manufacturers are required to provide UK DoC to market supervision agencies upon request.

The information required for a declaration of conformity will be essentially the same as the information currently required for a declaration of conformity in the European Union, and may vary depending on the applicable regulations, but typically should include:

Name and detailed business address of the manufacturer or its authorized representative

◆ Product serial number, model or model identification

Declaration (fully responsible for the compliance of the product)

◆ Detailed information of the authorized institution for executing the qualification assessment procedure (if applicable)

◆ Relevant regulations that the product complies with

Name and signature of UKCA DoC signatory

Date of statement release

◆ Supplementary information (if applicable)

In addition, it will be necessary to list:

◆ UK regulations, not EU regulations

Please consult NormalTCI for specific questions

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