This in no way constitutes legal advice! It’s a brief introduction to familiarise designers with the general workings of the CE Mark system.
Designing a new product is like fighting a three headed monster:
- Technical and design challenges associated with the product itself.
- The acceptance issues around people using and adopting a new product.
- Compliance with standards, and intellectual property considerations.
Which can be simplified to the following:
- Design and tech.
- Psychology and sociology.
Most designers are comfortable with 1 because it’s what they’re trained in. But 2 and 3 are much scarier, and can take a shockingly long time.
I’m going to focus on 3 for this article, since it’s something I’ve been grappling with recently. It will also be a EU centric discussion, since it’s where I’m based.
Before you can sell a product in the EU which you’ve either manufactured or imported and are selling under your name you need to check which CE marks apply to it.
Not all products are covered by CE Marks, but if you have designed a toy, or a piece of electrical equipment, then you’re almost guaranteed to require a CE Mark on your product.
First challenge - deciding what your product is.
There are several ‘directives’ which cover different product types. It’s up to the manufacturer to decide which directives their product falls under. Here is a list of the directives.
Once this is decided they have to comply with the standards referenced in the relevant directives.
CE Marks are self certified, which means that the manufacturer declares that their product is compliant with the relevant directives, and affixes the CE logo to their product. However, they must keep a folder showing that they have taken all the necessary steps.
Most manufacturers wont have the equipment in house to prove that their product is compliant (especially for the Electromagnetic Compatibility directive), so the manufacturer needs to take the product to a test house to get this done.
What if you just want to test a few prototypes?
CE Marks are required when the product is available commercially on the market, so prototypes are ok - but it has to be made clear to any users that they are prototypes.
If I make a change to my design do I have to self certify again?
If the product is functionally changed then the likelihood is that you’ll have to re-certify. If something like the colour is changed, and that’s all, then you’re likely to be ok.
What if I give away my product for free?
Even products which are given away for free have to comply with these directives. Furthermore, second hand items imported into the EU also have to comply.
Are products which require self assembly exempt from CE marks?
This is a tricky one. If you sold a plain circuit board and a bag of parts (for a flashing LED circuit), then it’s unlikely to require certification.
But if the kit contained a sub assembly which you manufactured yourself then the subassembly may still require certification.
And if one of the components is a radio transceiver, then this could require CE marking.
There’s no clear answer here - the best option is to ring a test house and get some advice.
Why CE marks are good
CE marks are actually good for product developers, because they harmonise the standards across all the EU member states. Without CE marks, you would have to look at separate standards for all the different EU countries, which would be incredibly onerous.
However, it can still be an intimidating prospect for first time product developers.