Explore how to comply with CE and UKCA regulations, the markings of which indicate that your product complies with the safety requirements of the EU and Great Britain and can be legally sold in these markets.

No matter where your business is based, if you sell certain products in these markets you’ll need to add the CE or UKCA mark to them and this post gives you an overview of how to do so and some important points to consider about the differences between the markings with a focus on general consumer electro-mechanical products.

 

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What is CE and what kinds of products does it cover?

CE covers all products within certain categories that are sold into the EU market. In short, it applies where safety is particularly important, nearly all electronics, electrical products above a certain voltage, PPE, toys and children’s products, measuring instruments, machinery, elevators, etc. See the full list here. However, a lot of products don’t need to bear the CE mark to be sold in the EU, such as garments, furniture, and more. You need to check if your product is one of these types because affixing a CE mark to products that don’t require could attract unwanted attention from market surveillance authorities. (00:38)

 

How to obtain CE marking: Overview.

Products that require a CE mark for sale in the EU have related regulations with harmonized standards – you can look up the relevant one for your product type and it will explain what you need to know.

The process roughly follows this path:

• Find the current harmonized standard(s) that apply to your product, it will start: EN xxxx, and once passed through various tests you have established ‘presumption of compliance’ and will have more assurance that your product is safe and compliant.
• Collect information that the market surveillance authorities demand and collect it in the product’s ‘technical file/folder.’ This includes product type, description, Bill of Materials, instruction manual, factory audit reports, and products test reports or certificates that show it has passed the tests required by the specific harmonized standard/s, among others.
• Declaration of Conformity (DoC): The manufacturer declares that the product conforms with the relevant regulation or directive. It will be translated into each language of the countries of sale, the technical file is attached to this, and all that should be done before the product is placed on the market.
• Add the CE mark to the product: this is supported by the DoC and all of the attached documentation. (04:22)

 

Who is ‘the manufacturer?’

If you import products into the EU made for you by, say, a Chinese company, but you don’t make their identity public as you prefer to keep your supply chain private, you will be seen as the manufacturer by the EU commission. This means that you will have to produce the DoC and shoulder the liability that comes with it. (09:23)

 

What are the risks if you don’t comply with CE?

If you start selling products in the EU without a CE mark, while they fall under one of the CE directives/regulations, it is illegal. You might be fined if the market surveillance authorities catch it, especially if they believe that they could represent a safety risk for consumers, and you may be obliged to do a product recall, or you might even wind up in prison. The penalty is likely to be related to the product type in question and whether you took any steps to do due diligence, such as some product testing and some due diligence about the factory. The authorities are not likely to take a positive view of importers of toys who completely flout the EN 71 standard, for example.

Small importers are less likely to be policed than large companies, but if injury or issues occur that attract the attention of the authorities they will naturally go after the local importer rather than a manufacturer in Asia because it’s easier for them.

The EU has taken controlling incoming products more seriously recently and has put pressure on Amazon and other e-commerce platforms to remove products that do not have the necessary paperwork and proof of compliance. (11:20)

 

What’s the difference between CE and UKCA?

Brexit marked the UK leaving the EU. Since then, the UK is having to redevelop its own laws and standards as it is no longer bound by EU regulations and directives. Where product safety is concerned, UKCA is the UK’s version of CE and there aren’t many differences between the two right now aside from that UKCA is governed by the UK and not the EU Commission.

As of now, CE-marked products can still be placed on the UK market without requiring a UKCA mark. From January 2025, products being sold into the UK market (excluding NI) must be UKCA marked, and CE alone will not be acceptable (a lot of products will probably have both in that case unless they are ONLY being sold in the UK). (20:38)

 

Why UKCA is not required for Northern Ireland.

There is no hard border between the Republic of Ireland and Northern Ireland, therefore NI will continue to use the EU framework for many things post-Brexit, otherwise, border checks would need to be reintroduced which is not possible. The UK government is planning to bring in an inclusive standard in due course, however. (24:51)

 

EU ‘harmonised standards’ are called ‘designated standards’ in the UK.

The standards are the same in their content right now, but they could change in the future so importers should be aware of this potential divergence and plan accordingly. (27:06)

 

The UK government is threatening to repeal a lot of EU laws due to Brexit. How realistic is this and why do they want to?

They need to ‘make Brexit work.’ It looks good for them to be taking back control from Brussels, but how realistic it is for them to repeal a lot of EU laws, etc, remains to be seen. Logically, they’ll probably try to repeal those that provide benefits quickly, especially economically. Overall, the people of Britain probably haven’t really seen the promised ‘Brexit benefits’ yet, if ever. (28:16)

 

Why seeing CE-marked products when sourcing from China might mean nothing at all.

When visiting the Canton fair or various suppliers’ showrooms in China you will see a lot of sample products with a CE mark, but be wary of this. Many suppliers will just add it because it’s expected, but the product has never been tested and formally shown to be compliant with EU requirements. It may also be the case that they made a product for a former customer who had tested it and legitimately obtained a CE mark, but the supplier has no documentation about this. Buying the product based on this would be risky.

Some Chinese suppliers do understand the certification process and have the paperwork to show for it, others don’t care because they know they’re unlikely to be classed as ‘the manufacturer.’

Really, for safety’s sake, YOU need to go through the process outlined earlier to establish product compliance (make sure that you have tested the product and have the DoC and technical file in hand when importing and selling it). After all, you’ll be held responsible if there are problems later on.

Also, the need for CE & UKCA marking applies to businesses from any country if they’re selling into those areas, so when sourcing you need to bear that in mind even if you are, say, an American company. (31:25)

 

What are notified bodies and when do they need to be involved?

A notified body is an EU/UK-authorized laboratory/testing house like TUV, Bureau Veritas, BSI, etc, which can do the testing and can verify conformity with EU or UK regulations. For many products, CE/UKCA marking is based on self-verification on the part of the ‘manufacturer,’ and of course notified bodies can be paid to verify overall compliance, but that’s not a must.

For certain products where risks are higher, such as Class II or III medical devices, there are more constraints. Paying for a notified body to audit the factory, test products, and verify overall compliance is mandatory.

If your product type does not require the involvement of a notified body, you can choose who does the testing and it’s certainly possible to select a testing lab that would be chapter than a notified body but can still provide you with the results you need. (35:35)

 

Related content to CE and UKCA…

• Official CE Marking Guidance
• The definition of manufacturers according to the European Commission
• Using the UKCA marking
• How To Verify that a Component’s FCC or CE Certificate is Legitimate?

 

Disclaimer

We are not lawyers. What we wrote above is based only on our understanding of legal requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.