There UKCA certification (UK Conformity Assessed) is the British mark introduced following Brexit to regulate the placing on the market of products that comply with safety and quality requirements within the United Kingdom. Despite repeated extensions of the use of the European trademark, which continued to allow the entry of goods into the British market, the industrial world gradually adopted the trademark without reservation. UKCA, recognizing its importance from both a regulatory and commercial point of view.
UKCA is not only a requirement to continue operating in the UK market, but also an opportunity for companies to consolidate their presence in this growing market. This article will delve into the technical implications of UKCA certification, its impact on the industry, and how companies can navigate the transition from CE to UKCA marking.
Regulatory Context of UKCA Certification
With the UK leaving the European Union, it became necessary to introduce a regulatory system that could replace the CE mark. From 1 January 2021, UKCA became the new compliance standard for most products placed on the UK market, covering a wide range of sectors including electronics, industrial machinery, medical devices and more.
However, to ease the transition and reduce the burden on businesses, the UK government has granted several extensions to the requirement to use the UKCA marking, allowing manufacturers to continue to use the CE marking until certain deadlines. The latest extension extends the ability to use the CE marking until December 31, 2024. Nonetheless, many companies have decided to adopt the UKCA marking early, recognizing that such a move not only ensures compliance, but can also represent a competitive advantage.
Differences between UKCA and CE: Technical Impacts
One of the main aspects of the transition to UKCA certification is the similarity with the European system. Both marks share basic principles such as conformity assessment and ensuring that products placed on the market comply with essential safety and quality requirements. However, there are key differences that are essential to understand, especially for companies operating in both markets.
1. Scope of Application
While the CE marking is valid in the 27 EU member countries, the UKCA marking applies only to United Kingdom, which includes England, Scotland and Wales. Products destined for Northern Ireland, however, must comply with the Northern Ireland-specific protocol regulation, which means they can continue to use the CE mark or the alternative UK(UK).
2. Certification Bodies
Another significant technical difference concerns the certification bodies. In the CE system, the Notified Bodies (Notified Bodies) based in the UK have been replaced by Approved Bodies (approved bodies) for the UKCA system. These approved bodies are responsible for the certification of products intended for the UK market and must be accredited by the UK Accreditation Service (UKAS).
Companies that have previously obtained CE certification through a UK Notified Body must now obtain a new UKCA certification from an Approved Body, if their product falls into categories that require third-party assessment.
3. Technical Documentation and Declaration of Conformity
While the documentation required for UKCA is similar to that required for CE, there are some key differences. For example, to obtain UKCA certification, manufacturers must prepare a Declaration of conformity UKCA specification, which certifies that the product complies with the applicable UK requirements.
This declaration of conformity must include information such as:
- Name and address of the manufacturer.
- Product Description.
- British regulations and standards applied.
- Approved Body information, if applicable.
- Signature and date.
Furthermore, the technical file must be available and contain all information demonstrating product compliance, such as laboratory tests, certificates, safety manuals and quality control plans. This technical file can be requested by the UK authorities at any time and must be retained for at least 10 years.
Industrial Sectors Impacted by UKCA
The UKCA certification covers a wide range of products, many of which are used in technology-intensive industries. Below is an overview of the most impacted industries and the technical implications of the transition to the UKCA mark.
1. Electrical and Electronic Equipment
Electrical and electronic equipment is one of the main sectors subject to UKCA certification. Relevant regulations include the UK Electrical Equipment (Safety) Regulations 2016, which establishes safety requirements for electrical devices operating at low voltages.
Companies manufacturing or importing electrical equipment into the UK must ensure that their products comply with these requirements and must carry out a conformity assessment through an Approved Body if the product presents high risks. They must also carry out extensive electromagnetic compatibility (EMC) testing and produce safety manuals for users.
2. Industrial Machinery
Industrial machinery is also subject to the UKCA regulations, in particular the Supply of Machinery (Safety) Regulations 2008These regulations aim to ensure that machinery is designed and constructed safely to prevent risks to operators.
Industrial machine manufacturers must provide a detailed risk analysis and implement appropriate safety measures, such as guards and interlocks. They must also ensure that the materials used to build the machines comply with British Standards and draw up a specific UKCA declaration of conformity.
3. Medical devices
In the medical sector, products must comply with Medical Devices Regulations 2002. UKCA introduced specific requirements to ensure that medical devices, including in vitro diagnostic devices, are safe and perform well.
Medical device compliance requires manufacturers to work closely with an Approved Body, especially for Class II and III devices, which present higher risks. Clinical trials and safety assessments play a key role in demonstrating compliance.
Business Benefits of Adopting the UKCA Brand
Despite the numerous extensions for the use of the CE mark, many companies have chosen to adopt the UKCA mark without reservations, evaluating the commercial advantages of this transition. Let's now see what are the main benefits deriving from the adoption of the UKCA mark.
1. Continuous Access to the UK Market
The main advantage of the UKCA certification is the ability to continue to introduce products into the UK market. This is critical for companies that view the UK as one of their core markets or see growth opportunities in sectors such as consumer electronics, industrial equipment and medical devices.
2. Consumer Trust and Business Partners
Early adoption of the UKCA brand can improve brand and product perception, increasing consumer confidence UK and trading partners. Customers see UKCA compliance as a guarantee that products comply with local regulations and meet stringent safety standards.
3. Compliance Risk Reduction
Companies that opt for an early transition to the UKCA mark reduce risks related to future deadlines and potential regulatory changes. Instead of waiting until the end of 2024, many companies prefer to certify their products with the UKCA mark now, avoiding disruptions in their supply chains and distribution issues.
4. Best Market Positioning
Adopting the UKCA mark allows companies to differentiate themselves from competitors who still rely on the CE mark. This is particularly relevant in sectors where compliance and safety are seen as key purchasing factors, such as medical devices and industrial equipment. Clear compliance with local regulations can positively influence customers' purchasing decisions.
Technical and Logistical Challenges of UKCA Certification
Despite the benefits, the transition to the UKCA brand also presents some challenges, especially for companies operating in multiple markets.
1. Double Certification
Many companies face the problem of double certification, as they must obtain both the CE mark for the EU market and the UKCA mark for the UK. This leads to additional costs for certification, the need to maintain two separate technical files and duplication of testing in some cases.
2. Reorganization of Supply Chains
Companies importing products or components from the EU to the UK also face the challenge of ensuring that their suppliers comply with UKCA requirements. This may involve changes to the supply chain and the implementation of new quality control processes to ensure compliance.
3. Technical Documentation Update
The need to draft new Declarations of conformity and updating technical documentation can be a burdensome task for companies that need to certify a wide range of products. It is essential that manufacturers invest resources in certifying their products and adapting internal procedures to ensure that all products comply with the UKCA mark.
Conclusion
The UKCA certification represents a major milestone for companies wishing to operate in the UK market. Despite the technical and logistical challenges associated with the transition from CE marking, many businesses have chosen to adopt the UKCA mark wholeheartedly, recognising its commercial value and the need for long-term compliance.
The timely adoption of UKCA enables companies to strengthen their position in the UK market, reduce risks related to future regulatory changes and improve consumer and business partner confidence.
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