Navigating regulatory compliance can be complex, confusing, and time consuming, especially in the ongoing case of CE marking for the EU vs. UKCA marking for Great Britain. Both labels signify that a product has been assessed to meet the highest health, safety and environmental standards and can therefore be traded on the region’s respective market, but the uncertain relationship between the two is causing a headache for technology manufacturers around the world.
The UKCA mark was the UK Government’s answer to replacing the European CE mark post-Brexit, since Great Britain would no longer be able to trade freely on the extended Single Market in the European Economic Area. By replacing the CE mark, products intended for use in Great Britain, including electrical and electronic equipment, machinery, radio equipment, toys and more, would need to undergo an additional conformity assessment to ensure adherence with new UKCA regulations.
Whilst most UKCA regulations mimicked their corresponding CE directive in technical content, there was still a duplication of labelling, declaration of conformity, and other documentation changes even for the majority of products that were not subject to third-party assessment. Where third-party conformity assessment was required, an additional cost and delay whilst the new UK approved bodies completed their re-assessment work would incur.
An indefinite extension to CE mark
The measures proved unpopular with industry, and on August 1st 2023 the Department for Business and Trade announced an indefinite extension to the use of CE marking for businesses using its 18 regulations, beyond the original deadline of December 2024. The change in approach was down to extensive engagement with industry and aims to cut business costs and help grow the economy. However, this extension only applies to those regulations under the responsibility of this government department. There is no change yet to the UKCA rules under other departments for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, marine equipment and ecodesign.
The government of UK prime minister Rishi Sunak has relaxed requirements around adapting to the new UKCA mark. Picture: WikiCommons
Now a new question poses itself: should technology manufacturers still adapt to the new UKCA rules? If yes; why, how and when?
After nearly 40 years’ experience in conformity assessment, working with BSI, UK government and the IEC conformity assessment schemes, I can appreciate this may feel like a quagmire. Whilst 18 product types are now privy to the indefinite extension, other UKCA regulations continue towards mandatory implementation. For example, medical devices or in vitro diagnostic medical devices will need to undergo UKCA conformity assessment by 30 June 2028 or 30 June 2030, depending on device type. Manufacturers in this sector should start the process now to allow for a smooth transition of their products to the new rules; particularly for those classifications involving third-party conformity assessment.
The value of UKCA to consumers
Amongst manufacturers of the 18 product types included in the extension, some may believe that they do not need to conform with UKCA relevant legislation, or that it’s an effective cost saving move to avoid it. But there are three flaws to this rationale. Firstly, the UKCA mark is now an indication to British consumers and other user groups that the product in question is confirmed as safe for use in that market, and if that disappears they may think that the item is no longer in line with product standards in England, Scotland and Wales. Similarly, if UKCA is already in an organization’s procurement rules then the absence of the UKCA mark could be a problem. Secondly, the indefinite acceptance model has assumed that there is no technical divergence between CE and UKCA rules. Since Brexit, the EU Radio Equipment Directive no longer supports warning marking for situations where the design is unsuitable for the permitted radio bands in Great Britain.
So how do you show that a CE marked radio is suitable, other than applying a UK specific mark? By early 2027, we will need to address the new EU Machinery Safety Regulations which will no longer correspond directly with the UK machinery safety regulations. Finally, as of today, there is still some uncertainty as to what the final rules for the Great Britain market will look like. Beyond the actual marking, it is not yet clear what remaining product conformity rules will be applied. This includes whether importer labelling is needed or what, if any, documentation will need to accompany the equipment if the CE marking route is chosen. Hence the indefinite recognition of CE marking may not encompass all the rules for the Great Britain market.
Keeping faith with UKCA
Taking all into account, if you are a manufacturer that has already entered the UKCA conformity process it may be wise not to recoil as there is a likelihood you will still need it. Also, the hard work in understanding the process has been completed, and many who do not need to use an approved body will have found that the additional work to list UKCA alongside CE is in fact minimal. It is worth noting that ‘indefinite’ indicates an unknown length of time and there is still scope for enforcement in the future. Similarly, if you opt for the CE mark there will be other UKCA related items in legislation that you have to follow. To prepare for all eventualities, we at Element advise our customers to integrate the new UKCA rules into their future plans for long-term security and as a future proofing tool.