Han Zuyderwijk (LinkedIN) is the founder of Amsterdam based CEmarking.net, and one of Europe’s leading experts on CE marking and EU compliance. In this article, Han Zuyderwijk explains what CE marking is, and what kind of product documentation European importers need. He also explains why compliance with the various CE marking directives if far more complicated, when importing from China. Keep reading, and learn everything you must know about CE marking, as a European importer.
When must a product be CE marked?
A product must be CE marked, when it is covered by one or more of the approximately 25 European Union technical regulations that require CE certification. These technical regulations are often called “directives” and sometimes “regulations”. CE marking does not apply to all types of products. For example: foodstuffs, pharmaceuticals, cosmetics and chemicals are excluded. Electrical equipment, electronics, toys, machinery, medical devices and personal protective equipment are among the products for which CE is required.
CE marking does not just mean adding a CE sticker to the product: before a product may be CE marked, it has to be brought into compliance with the requirements of the applicable CE directives and European harmonized standards. Also the compliance must be certified according to the directives’ procedures.
How do you identify which EN directives apply to a certain product?
Unfortunately, there is no easy way to do this: basically, one would need to find, download and read the 25+ directives to determine if the product is included in their scope and not exempted. This can be painful, considering that directives can change, or new directives may be introduced. We are not even talking about the European standards, that are amended even more regular. My colleagues and I have seen how companies are struggling with this, and we have been working hard to offer a solution. More on this below.
What sort of documentation is required?
The manufacturer needs to keep (and maintain) a Technical File with all the documentation that is necessary to prove the product’s compliance. The Technical File contains more than a test report or certificate. Although the content of the Technical File may differ from one CE directive to another, as a minimum it will contain:
1. Design documentation; (i.e., Circuit Diagrams)
2. Declaration of Conformity (Read more)
3. Test reports and certificates
4. Risk analysis (Read more)
5. Copy of the user manual or instructions for use
6. An overview of the European standards that have been applied
The manufacturer must keep the Technical File available for at least 10 years after the moment that they stop placing the product in the market. There is no registry for Technical Files. The Technical File does not need to be shared with customers. The manufacturer must present the Technical File to the market surveillance authorities of the EU Member States upon their request, if they want to check the product’s compliance.
In what cases must product certificates be issued by a third party, and in what cases by the manufacturer?
There is no general answer to this. Every CE marking directive has another procedure. I can say that only for approximately 10% of the products there is a requirement to involve a third party certification body. The other 90% may be self-assessed or self-certified by the manufacturer.
Some directives have a list or categories of products that require third party certification. In other directives a third party certification body is only required when there are no European harmonized standards available for the product, or when the manufacturer deviates from these standards. It is best the manufacturer checks the applicable CE marking directive(s) to determine if a certification body must be involved in the conformity assessment.
As said, actually only for a few products it is required to have the conformity certified by a third party. Let’s look at some of the most general applicable CE directives:
- Machinery: only 17 groups of high-risk machinery (such as sawing machines and press machines with manual loading/unloading) are listed as machinery that may need to be certified by a third party. Even these 17 groups of machinery do not require the intervention of a certification body if the manufacturer applies the applicable European harmonized standards. That means that the great majority of the machinery may be self-certified.
- Electrical equipment: in almost all cases electrical equipment does not need to be tested and certified by a third party certification body.
- Electronics: electronics do not need to be tested and certified by a third party certification body, if the manufacturer applies the available European harmonized standards.
- Medical devices: Class I medical devices that are not sterile or have no measuring function do not need to be tested and certified by a third party certification body.
- Construction products: a large group of construction products do not need to be certified by a third party certification body.
- Pressure equipment: a large group of pressure equipment do not need to be certified by a third party certification body.
- Toys: almost all toys can be self-certified.
Just for clarity it is good to note: even if self-certified, the products still must be tested, and the test reports must be provided in the Technical File.
In the case a certification body is involved, they will issue a Certificate of Conformity and the manufacturer will include this in the Technical File. In all cases, the manufacturer will issue a Declaration of Conformity, confirming compliance with the applicable CE directives and standards.
Does this also apply to non-EU based suppliers, for example, Chinese manufacturers?
All requirements of the CE marking directives apply to the manufacturer irrespective of his/her location in the world. Chinese manufacturers must fulfill the obligations of the CE directives if they have the intention of making their products available in the European Union. Obviously, we have to remember here that the market surveillance authorities in the EU Member States do not have to competence to enforce EU rules in China. They will focus their actions and measures on the European importers.
Based on your experience, what are the biggest compliance related challenges facing European businesses importing from China?
I think the biggest pain related to CE marking of this group is that they are fully liable for CE marking, but they are not in control of the product’s design, production and compliance. They fully have to rely on their Chinese supplier. However, is the product really compliant? Many companies do not know how to check and assess product compliance.
Also, the directives and particularly the standards change on a regular basis. This means that the certificates and reports they receive from their manufacturers today, may not be valid anymore tomorrow. Since they are fully liable, the importers need to familiarize themselves with the requirements, and make sure to stay up to date with the latest developments.
How can your company help EU based businesses ensure compliance with EN directives?
From working in this field for almost 20 years, we know that CE marking can be quite daunting and confusing. Our customers appreciate particularly the following services:
Kick Start: If the company is brand new to CE marking, we help them to determine if CE marking applies, and if so which CE directives and standards their products need to comply with. We show them how to get CE marking in a time-efficient and cost-effective way. It is maybe good to note that we are not a test laboratory or certification body, and so we don’t need to sell those services.
Documentation Review and Gap Analysis: We can help importers get the confidence they are looking for that the products they import are compliant and the documentation real. We offer a documentation review and verification of the available compliance documentation, and report on the possible gaps and irregularities.
Consulting and Coaching: For those customers that prefer a “No-Hassle” approach, our experts will conduct the conformity assessments and prepare all the required paperwork. If they want help, but prefer to keep the costs low, we offer coaching. In a few online one-on-one coaching sessions, an expert will walk the customer through the process, show them what to do and provide them with templates and checklists where available. This way the customer can complete the CE marking themselves, while the coach ensures there is progress.
easyCE, CE Marking Management Software: I am glad that I can give Chinaimportal a scoop, and that today I can unveil our plans to launch an online CE marking management platform. We mentioned how manufacturers and importers struggle to determine the applicable directives and standards. We also spoke about their pain of staying up to date with the regulations, and how to ensure the products comply with the latest versions. The easyCE platform will solve those issues. On top of that, it will help the user to build their Technical File and Declaration of Conformity, and to keep them up to date.
The user can upload and maintain their compliance documents, and have them checked and verified by our experts. We’ll be happy to inform your audience when easyCE launches in the next couple of weeks. We even have a special offer for Chinaimportal visitors. To read all about that and to register for the Early Bird notification list, go to this page.
In any case, don’t take my word for it. Read what our customers have to say about our services at cemarking.net/testimonials. The easiest way to let us help get you started with CE marking is to complete this survey here: cemarking.net/start