UKCA Marking and Certification

UKCA marking and certification are a legal requirement for all companies wishing to sell products in the UK market. UKCA stands for "UK Conformity Assessed", which means that the product meets UK regulatory standards and is therefore safe for consumption. The UKCA marking has been in effect since January 1, 2021, replacing the CE marking that was previously used in the EU. To obtain the UKCA marking, companies must demonstrate that their products meet UK regulatory standards by completing a conformity assessment. This assessment can vary depending on the product type and category, and typically includes testing of safety, health and environmental aspects. UKCA marking is an important step for companies looking to succeed in the UK market, and it is important to familiarize yourself with the requirements and process of certification.

Which products are affected by UKCA

UKCA marking and certification are mandatory for all products wishing to be sold on the UK market, provided they are subject to the relevant regulatory standards. This applies in particular to products covered by EU directives and regulations that were in force before Brexit. These include, for example, electrical appliances, toys, medical devices and construction products. Even products that were not previously subject to certification may now be subject to UKCA certification requirements as a result of Brexit. However, the UK government has introduced transition periods for the certification of certain product categories. For example, products covered by the Low Voltage Directive can continue to be CE marked until Jan. 1, 2023. However, they must bear the UKCA marking no later than January 1, 2023. It is important to be aware of the respective transition periods and certification requirements for each product category. In summary, all products to be sold in the UK market will be affected by UKCA marking and certification, provided they are subject to the relevant regulatory standards. Companies should familiarize themselves with the requirements and transition periods for their respective product categories to ensure that their products are certified and therefore suitable for sale in the UK.

UKCA marking: cost, duration and validity

• What is the cost of the UKCA mark?
  The cost of UKCA certification can vary depending on the product type and certification body. It is therefore important to find out the exact costs in advance in order to plan the cost of certification into the product budget.

• How long does it take to get certified?
  The time required to obtain UKCA certification depends on various factors, such as the complexity of the product and the availability of the necessary documentation. As a rule, certification takes a few weeks to months. It is therefore advisable to start the certification process as early as possible to ensure that products can be certified and sold on the UK market in time.

• How long is the UKCA label valid?
  The UKCA marking has no specified period of validity. However, it is the responsibility of the manufacturer to ensure that the product continues to meet the applicable requirements and maintains the required compliance. If there are changes to the product or requirements, it may be necessary to update or reapply for certification.

Certification for the UKCA mark can be an extensive task, involving many different documents and requirements. But with Regul.ai's software, this work can be significantly shortened. In the UKCA Collection, all required documents are centrally collected and perfectly prepared by Regul.ai's AI. This means that all requirements can be quickly identified per document, saving time and effort.

Does the UKCA mark also apply to products that were approved on the UK market before Brexit?

The UKCA mark has been mandatory for certain products sold in the UK since January 1, 2021. However, for products that have already been approved on the UK market before this date, transitional arrangements apply that allow these products to continue to be marked with the CE mark until December 31, 2021. From January 1, 2022, however, the UKCA mark will be mandatory for these products.

Consideration current extension of the transition period

On Nov. 14, 2022, the Department for Business, Energy & Industrial Strategy ("BEIS") postponed the original deadlines for mandatory UKCA certification and marking by an additional two years.

For products falling within the scope of European CE marking, the obligation to issue a UK Declaration of Conformity (where mandatory after conducting an external conformity assessment procedure) and to use the UKCA mark will not be introduced for placing on the market in the United Kingdom ("UK", i.e. England, Scotland, Wales) until Jan. 01, 2025.

Until the end of 2024, products may still be placed on the market that previously only bore the CE mark.

From Jan. 01, 2028, it will be mandatory for the UKCA mark to be affixed to the product, while in the transitional period from 2025 to 2027, marking of accompanying documents will be permitted.

What steps are required to change an existing CE marking to a UKCA marking?

For products that already have a CE marking and are approved on the UK market, it is necessary to change this marking to a UKCA marking if they are to continue to be sold on the UK market from January 1, 2022. To do this, the products must undergo a conformity assessment in accordance with the UK regulatory framework and a UKCA mark must be affixed to the product. However, depending on the product and the conformity assessment procedure, the steps and requirements may vary.

What changes may result in the need for UKCA re-certification?

UKCA re-certification may be necessary if there are significant changes to the product or its components that could affect the product's compliance. Examples of such changes could include: changes to design or construction, changes to materials or manufacturing processes, changes to safety requirements or environmental standards. In such cases, it is necessary to carry out a new conformity assessment and, if necessary, apply for a new UKCA certification.

Regul.ai also makes collaborating on a document very easy. Work on existing documents or upload your own documents. Simply select a paragraph and choose your colleague who should also read this paragraph. You can also leave a message or task for the colleague.

What is the certification process for UKCA certifications and what steps are required to obtain a successful certification?

First, the manufacturer or distributor of the product must research and understand the applicable standards and guidelines that apply to the product and its target market. Then, the product's conformity and compliance with those requirements and standards must be evaluated. This typically involves a comprehensive evaluation of the product, including its design, function and related documentation. Once the conformity of the product has been confirmed, the manufacturer or distributor must engage the services of an approved conformity assessment body (Notified Body) to verify the conformity of the product and issue an EU Declaration of Conformity (or UKCA Declaration of Conformity). Once the conformity assessment procedure has been successfully completed and a Declaration of Conformity has been issued, the product can be UKCA marked and launched on the UK market. It is important to note that the certification process is individual for each product and may vary depending on the product type and complexity. It is advisable to seek professional assistance to ensure that all requirements are met and certification can be successfully completed. Regul.ai offers this professional assistance as an additional service.