Check out my video explaining what CE marking is.
I made this short video presentation to answer some of the basic questions about CE marking. Do you like it? Please comment below. Which specific CE marking questions would you like me to answer in a video like this one?
Video: What is CE marking?
About Han Zuyderwijk
Han is an author, speaker and consultant specialized in CE certification and European technical regulations. Founder of CEMarking.Net. See Google+ ProfileConnect
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24 Responses to Video: What is CE marking?
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Hello Han, A very nice introduction to CE Marking. We are Adistem, a biotech company from Australia which has developed a low level LED light product for activating stem cells taken from a person’s fat. We are currently debating whether we should get UL testing and CE marking for a medical device or as laboratory equipment. What is the difference between the two CE Marks?
Best regards,
Nick Ede
CEO, Adistem
Hi Nick, there are no two CE marks. There is only one. A CE mark will indicate compliance with all directives that apply to it. In your case, you are probably looking at the Medical Devices Directive (93/42/EEC) and the Low Voltage Directive (2006/95/EC) and EMC Directive (2004/108/EC). All of these are directives that require the CE marking.
Which one apply/applies is difficult to say without studying the technical specification of your product. If you want me to do this, please order the service from the following page:
http://www.cemarking.net/services/ce-jump-start/
Thank you.
Hello, thanks for this site!!!
I am thinking about importing wooden toys from China to Europe (Italy), I would know if it is sufficient that chinese firm gives to me EN71 certification.
I spoke with a italian organism of CE certification, but they sell their service, they said to me for 40 products they request at least 100 euro for products so I have to give them about 4000 on 10000 of net value of products I would import, the 40% !!!!
Is it sufficient to have certification from chinese firm on market from 10 years?
It makes me a LITTLE strange that it is this cost, because the discount of import there isn’t anymore in that way.
I ask also if I register on this site if you can help me on how to do, please. It is important.
Thanks in advance
Useful vidio , thank you for briefing in a good & easy way.
Hello, Mr. HAN…
The most useful video i have seen..
i have just entered info a professional industry from college life &
u have explained the things in so simple way that i really want appreciate you by heart.!!
i remember one of my professor was really like u who used to simplify the things very nicely.
I would be happy if i can get more info about UL, CSA, IEC & IP standards also.
kindly suggest if u have such a video about that.
i wish u all d best for future..
Thank you Sumit. That’s a very nice compliment. I am glad you like it.
Hello Sir,
With due respect, Just want to ask that i.m willing to export a bandage scissors to Ireland and im confused how to mark ce certification on that, i have manufacturing unit in Pakistan, please tell me where should i contact in Pakistan to get my company registered with Confirmity CE. THANKS IN ADVANCE. KADRI
Thank you for your question. My company does not have a representative in Pakistan. But maybe we can help through our on-line sources. You maybe interested to take the free on-line mini course to get you started. You may also be interested in the Six Boxes CE Self-Certification Course. Don’t hesitate to send me your questions.
The EN 71 is a European harmonized standard that pertains to the Toys Directive (which requires CE marking for toys). This means that if your toys comply with this Directive, they are deemed to comply with the Toys Directive.
However, please be aware that at the moment I am writing this reply, there are 8 different parts in the EN 71-series. And to be allowed to affix the CE marking on the basis of the standard, the toys must comply with all relevant parts. So that is something you’ll need to check.
Hello Han, I have a question, hopefully you can answer to it, and I have been in contact with Chinese manufacturer (toys) as I’m thinking of importing toys into Europe from china. Asked them if they have CE certificate, they replied as they are EN71 certified. Is that same as CE?
Thank you.
P.S. Great website!!
Hi Han,
very useful website.I write from Switzerland.
Are you familiar with the implication of CE marking implantable medical devices? It looks like companies as small as 5 employees, small spin offs from universities, can receive a CE mark for their product and in our company the QA is making a big fuss of the requirement needed in the company quality system in order to register our products though a Notifying Body. They are concerned of the costs associated to the post-marketing surveillance and upgrade of quality system. Any idea whether this is true? If yes, Would there be alternatives to such a complicated and expensive procedure?
Thanks a lot for your help.
Hi Marina,
I am glad you like the website.
Yes, the implications of the AIMD directive can be that you need to install or upgrade a quality system. In your case, the quality system will be one of the points that the Notified Body will check. But that does not automatically mean that the costs will be astronomical. There are certainly things you can do to prevent budget waste:
1. Normally, the first thing to do is to check if self-certification under module A is allowed. With active implantable medical devices this is not possible, and so you must involve a Notified Body;
2. You are free to choose a Notified Body. And it is generally a good idea to contact a few before choosing. Price can be one of the criteria.
3. There are certainly a lot of things that you can do yourself, or with help of other service providers than a Notified Body. For example, to upgrade your quality system, you don’t need the NoBo to intervene. You can do this in your company (when necessary with help of a consultant).
But also some tests and assessments can be done in house or in accredited labs. However, you should discuss this with the Notified Body, because they must accept this route and they must accept the results of any external lab you contract.
You understand that it is quite difficult to give you good advice without knowing the details of your specific case. But I hope this answer is still helpful. Contact me if want to discuss this further in more detail.
Hej HAN,
I from sweden.I need to put CE marking on our product.But dont know what to do for put CE marking on our product.
please reply as soon as possible
Hello, thank you for your question.
Unfortunately, there is no easy answer to your question. The CE requirements and conformity assessment procedures differ from one product to another. They are defined by the CE marking regulations (“Directives”) that apply to your product.
In general the procedure is like this:
1. Find out which CE directives apply to your products.
2. Once you know this, you can determine which requirements and conformity assessment procedures apply (and you will know whether you can do self-certification or whether you need to involve a 3rd party certification body).
3. Find out whether there are European harmonized standards for your products under the CE directives that apply. These standards may help you in the conformity assessment.
4. Apply the CE requirements and relevant standards to your product design. Solve non-conformities in the design, or when not possible, in shielding and safety measures.
5. Where necessary conduct tests, risk analysis’, inspections and other assessments and make sure to document them in reports.
6. Make users instructions.
7. Make a Technical File.
8. Draw up the Declaration of Conformity.
9. Affix the CE marking.
You may not understand all terms I mentioned, and maybe you’d like more explanation. I made a free mini course that explains all this in more detail. You can sign up for this mini course at the following page:
http://www.cemarking.net/free-ce-marking-mini-course-and-newsletter/
Please note that at this website we also offer some courses and solutions to assist with the different steps I mentioned above. Look at http://www.cemarking.net/category/solutions
And when you prefer a personal consulting session, that is also possible.
I hope this helps.
thank you
Hi
I am looking at products from China with CE certs can these be trusted, and how do I find out if they are genuine ?
Hi Paul, see my answer to Braam.
Hi Paul,
Thank you for your question. Did you see my answer to Braam? It actually answers your question as well..
Han, Is this a mark of conformaty or a quality assurance mark?
Is there a difference between the two? It seems that anyone can make a little sticker and stick to a piece of equipment.
My concern is especially with medical equipment and trying to make sure that equipment purchased will actually function as required
Dear Braam,
Its a conformity marking. Yes, anybody can make a little sticker and affix it. But by affixing the sticker, the person indicates that the product complies, and s/he bears responsibility for that.
Your point illustrates that you always need to check. I suggest that you always ask for the Declaration of Conformity and check if the information is accurate. And when in doubt, ask for test reports, certificates etc. But keep in mind that even certificates and reports can be false.
My recommendation: familiarize yourself with the European requirements for your main products, so you will be able to spot non-compliances more easily.
Hans, you gave so much good advice when I first brought my product to market, that without this advice I could have lost my business and product to some unsavoury people. Your website is the best I have seen to help people looking to place a product on the market. Thank you for all the hard work and committment you show.
Thank you very much for your kind words. I am glad you like the website.
Where can I lookup a specific vendor to see if their product has a CE certification?
There is no central database in which all CE marked products are registered. There is the database of CE-approved.org and there you can try? But that register is voluntary and would only give results when the product has been registered by the manufacturer. If the product has been certified by a third party, you can contact that party and ask them to confirm the certificate.