An introduction to UKCA certification

UKCA is short for UK Conformity Assessed.

Like the CE mark, the UKCA mark is the responsibility of the manufacturer to ensure that the product complies with the standards stipulated in the law, and after self-declaration in accordance with the prescribed procedures, make the corresponding mark on the product.

Manufacturers can seek tests from qualified third-party laboratories to prove that the products meet relevant standards, and issue AoC, which is the basis for the manufacturer's self-declaration DoC.

UKCA certification will replace the current EU CE certification, and most products will be included in the scope of UKCA certification. In terms of market access for electrical products, the CE marking scheme will continue to be implemented.

After March 29, 2019, the following products will no longer be able to use the EU norms and conformity marks in the UK market:

1. Automobile (vehicle type certification);

2. Aerospace (aviation safety);

3. Pharmaceutical products (batch testing of drugs; drugs, medical devices and clinical trials; further regulation of drugs, medical devices and clinical trials; regulatory information on price-raising medical products);

4. Medical devices (drugs, medical devices and clinical trials; submission of regulatory information for medical products);

5. Chemicals (management of chemicals, classification, labelling and packaging of chemicals);

6. Items regulated by national regulations (non-coordinated items).

When to use the UKCA logo

At present, most products covered by the CE mark will also fall within the scope of use of the UKCA mark.

The rules for using the UKCA mark are basically the same as those for the CE mark.

Manufacturers can still use CE marking for products circulating in the UK market, unless the product requires a third-party conformity assessment and must be carried out by a UK conformity assessment body, in which case the manufacturer must Then apply for the new UKCA mark.

Manufacturers can still use the CE mark to sell on the UK market if a mandatory third-party conformity assessment has been carried out by an EU-recognized conformity assessment body, or if a previous certificate of conformity issued by a UK body has been moved to an EU-recognized conformity assessment body product.

If the product currently only has a self-declaration of conformity for the CE mark, for products within the scope of the mark, the manufacturer can use the UKCA mark based on the self-declaration. In this case, the manufacturer may use either mark, or both the UKCA and CE marks on the same product.

The UKCA mark will not be recognized in the EU market, and products that currently require CE marking still require CE marking for sale in the EU.

UKCA general rules are as follows:

The UKCA mark may only be affixed to products as the manufacturer or his authorised representative (where permitted by relevant law);

When affixing the UKCA mark, the manufacturer assumes full responsibility for the product's compliance with relevant regulatory requirements;

Manufacturers must only use the UKCA mark to demonstrate that the product complies with the relevant UK regulations;

Manufacturers must not place any marks on third parties that may misinterpret the meaning or form of the UKCA mark;

Manufacturers must not attach other marks to the product that affect the visibility, legibility or meaning of the UKCA mark;

The UKCA mark cannot be placed on products unless there is a specific requirement in legislation.

Rules for affixing images of the UKCA logo

1. The UKCA logo must be reduced or enlarged according to the specified ratio;

2. The height of the UKCA logo shall be at least 5mm, unless otherwise specified by relevant regulations;

3. The UKCA logo must be easily identifiable, clearly visible and of high durability.

Technical Documentation

Manufacturers or their authorized representatives must maintain technical documentation to demonstrate that their products comply with regulatory requirements. Market surveillance or law enforcement agencies may request this information from the manufacturer at any time. Available up to 10 years after the product is placed on the market.

Record-keeping requirements will vary depending on the specific regulations applicable to the product, but generally:

1. Product design and manufacturing records;

2. How to prove that the product meets the relevant requirements;

3. The address of the manufacturer and any storage facility.

The information should be stored in the form of technical documents, which can be made available to market surveillance agencies.

UK Declaration of Conformity

The UK Declaration of Conformity is a document developed for most products that legally use the UKCA mark. In this document, the manufacturer or its authorized representative shall:

1. Declare that the product complies with the requirements of the relevant regulations applicable to the specific product;

2. Make sure the document contains the name and address of the manufacturer or his authorised representative, as well as information about the product and the conformity assessment body.

Manufacturers must provide a UK Declaration of Conformity to market surveillance agencies upon request.

When using the CE mark, manufacturers also need to prepare an EU Declaration of Conformity.

Consult I89273O8I27