Developing smart, internet-connected devices and bringing them to market is the exciting part of the process. However, as always, there are certain rules that must be adhered to. These are built around hardware and software requirements designed to make devices safer for end users. With the growing number of IoT devices, ensuring they remain compliant with regulations is essential; ultimately, being compliant is the prerequisite for selling devices in any given market.
Following Brexit, the United Kingdom introduced its own set of regulations for devices sold in Great Britain, modelled on the European CE marking system. The UK Conformity Assessed (UKCA) certification is now a mandatory element of your product. While the move was intended to establish regulatory independence, the technical requirements for the UKCA mark are currently almost identical to those for the CE mark. The UK largely “cloned” the EU’s New Approach Directives into domestic law. But still it is important to understand requirements and differences between UKCA marking and CE.
What is the UKCA marking?
After Brexit, the UK government wanted to have a different set of rules from the European Union across all areas, including IoT devices. Because of this, the UKCA marking has been in power since the beginning of 2021. This rule applies to all products placed on the market in Great Britain (England, Scotland, and Wales) and covers all goods which previously required the CE marking.
Since then, they have made some changes to the policy. Although it was intended to fully replace the CE marking, it has ended up that both are acceptable. If a product already has the CE mark, it does not necessarily have to obtain the UKCA mark. Most manufacturers, wanting to be sure they can sell devices no matter what. That’s why they use dual marking – placing both CE and UKCA on the box. This way, manufacturer ensure their products can be moved freely between the EU and the UK without making changes.
Placing the UKCA marking comes with specific requirements. Only the manufacturer or a United Kingdom Responsible Person is allowed to place the UKCA marking on a product label. When the marking is placed on a device, it means it is compliant with applicable regulatory requirements. And the manufacturer is responsible for this compliance. It should be affixed to indicate the product’s compliance with relevant UK regulations. Any other markings that distort the meaning or form of the UKCA marking, or that affect its visibility and legibility, should not be affixed.
What products need UKCA marking?
The scope of the UKCA marking indicates exactly which products fall under these regulations. Being familiar with it is important for manufacturers planning to place products on the UK market. It spans over 20 product categories that must meet specific requirements, ranging from toys to pressure equipment. While the full list is available on the official UK government website, we are going to focus on IoT and medical devices.
IoT devices
Internet of Things devices can be divided into further categories such as smart home, wearables, and industrial. Most “consumer” electronics also fall under the Radio Equipment Regulations 2017, which specifically regulate these requirements. This means all devices equipped with Wi-Fi, Bluetooth, or any communication protocol whether an intelligent heater or a fitness tracker must also comply with Electromagnetic Compatibility (EMC) regulations in terms of electrical and electromagnetic safety.
Cybersecurity and PSTI
Which is also important, since 2024, manufacturers in the United Kingdom must also be compliant with the Product Security and Telecommunications Infrastructure (PSTI) regulations. This places more responsibility and obligations on them. Besides standard hardware safety, products must meet more complex requirements for the whole device. For example the absence of default passwords and a transparent vulnerability reporting policy.
Medical devices
MedTech devices are treated even more restrictively and fall under the Medicines and Healthcare products Regulatory Agency (MHRA). Here, the scope is even broader because it covers physical health monitoring devices as well as software. Initially, the plan was to rely fully on the UKCA marking for medical devices and stop accepting the CE marking. However, because regulators did not want to disrupt trade between the EU and the UK, they decided to allow some flexibility. Manufacturers are now permitted to bring devices to market with only a CE marking. Companies have time until 2030 to adjust to the new regulations.
It is important to keep in mind that this division into IoT and MedTech devices often happens simultaneously, as modern medical devices frequently have connectivity. Therefore, they must comply with both sets of regulations. For manufacturers, this means they must carefully verify which of the 20 product categories their devices fall under.
What are the exemptions for UKCA?
Understanding exemptions requires a clear distinction between being exempt from safety regulations and the requirement to affix the UKCA marking. In 2026, the most significant exemption for manufacturers is the indefinite recognition of the CE marking for most consumer goods. This means that if your product already carries a valid CE marking, there is no need to undergo the certification process for the UKCA mark. This flexibility is intended to prevent trade barriers, though it primarily applies to standard electronics and radio equipment.
For MedTech devices, the transition period is more strictly defined. Although CE certificates for medical devices are currently accepted, this recognition is set to expire in 2030. There are also products that have been completely excluded from the UKCA requirement since the beginning. These exemptions mainly cover products such as batteries, medicinal products, and specialist military equipment. They are subject to their own specific safety protocols and do not require a standard UKCA conformity assessment.
It is worth keeping in mind that while IoT devices may not require a UKCA mark because they already have CE certification, they must still be compliant with PSTI regulations. The only exemptions from PSTI are Personal Computers and MedTech devices that fall under rigorous medical regulations. For manufacturers of smart home devices or wearables, PSTI compliance is mandatory, even if they are exempt from the UKCA marking.
Is UKCA the same as CE?
They might seem like two separate sets of regulations, but for now, they are technically equivalent “twins”. The aim of both is to confirm that a device meets rigorous safety, health, and environmental standards. The main difference lies not in the physical construction of the device or lab testing, but in jurisdiction and legal documentation. While the CE marking is mandatory for legally selling devices in the European Union or Northern Ireland. The UKCA mark is the official post-Brexit substitute for Conformité Européenne in Great Britain.
As a result, the technical requirements for smart devices sold in the EU and the UK are currently virtually identical. British standards (known as “designated standards”) largely correspond to EU harmonised standards. The primary difference lies in the documentation and the referenced acts. For example, the Declaration of Conformity for the CE mark must refer to EU directives (such as the Radio Equipment Directive (RED)), whereas the declaration for the UKCA mark must refer to the relevant UK legislation (such as the Radio Equipment Regulations 2017).
For manufacturers, the most important factor is that the UK government has introduced indefinite recognition of the CE marking for most consumer goods. This means that if your IoT device bears the CE mark, it is fully compliant and accepted throughout the UK. This makes the process of bringing a device to market much simpler and faster. Removing the necessity of undergoing a second certification when the requirements are nearly identical.
Conclusion
Bringing IoT devices to the UK market in 2026 requires a clear understanding of the regulatory landscape and its various advantages. Despite the UKCA mark being introduced to replace the CE marking, both are currently equally acceptable. The most significant point for manufacturers remains the fact that the UK has recognised the CE marking for most goods indefinitely. In practice, holding EU certification provides full access to the markets in England, Scotland, and Wales. This removes the need for costly and duplicative certification procedures.
It should be borne in mind, however, that the “twin” nature of these regulations primarily concerns technical and hardware-related aspects. The key to full compliance lies in a meticulous approach to documentation and an understanding of specific UK requirements. For developers and manufacturers, the reality is that while the specific mark on the box may be optional, the underlying standards are not.
Success in the UK market now requires a two-pronged approach: maintaining high-quality technical files that satisfy both EU and UK authorities, and ensuring that IoT-specific security is ‘baked into’ the product from the outset. By focusing on these technical fundamentals rather than the shifting politics of marking, you can ensure your devices remain legally compliant and accessible to customers on both sides of the Channel.
