A person checking a digital label.

Digital labels to become reality in the United Kingdom

In January 2024, the United Kingdom announced further measures to ease regulatory obligations for companies. With the introduction of digital labelling and a more flexible use of the CE and UKCA markings, the governmentā€™s goal is to allow companies to save costs and time for products sold in the UK.

No digital labels for medical devices and IVDs

The United Kingdom is going to allow businesses to use digital labelling for a wide range of products. By making information available online rather than printed on the product, the UKā€™s Trade Minister commented that this ā€œwill not only ease business burdens and costs but will enable them to spend their time growing their companies and creating jobsā€.

Medical devices and IVDs do not have the option to show the relevant information exclusively on their websites. Labels and IFUs of medical devices and IVDs sold in the UK must accompany the product itself.

CE marking recognition and Fast-Track UKCA

Remarkably, in January 2024, the United Kingdom announced that they will also introduce a ā€˜Fast-Track UKCAā€™ process, which will allow manufacturers to use the UKCA marking to demonstrate compliance with either UKCA or recognised EU conformity assessment. In the case of more applicable regulations, manufacturers will have the possibility to combine conformity assessment paths from both EU and UK regulations.

Currently, manufacturers can use both the CE and UKCA markings to demonstrate compliance of their products. Specifically, the UK recognises the CE marking for products falling within the scope of 21 regulations. Among these products, there are electronics, toys, machinery, pressure equipment, equipment for potentially explosive atmospheres (ATEX), and personal protective equipment (PPE). Consequently, businesses can choose whether to use the CE or UKCA marking to sell products in Great Britain (England, Wales, and Scotland).

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