The responsibility for product compliance with CE marking requirements lies with the manufacturer. However, when the manufacturer is located outside of the European Union, and did not comply with the requirements and procedures, the importer can be held accountable.
In the new rules that have been introduced in 2008, the importer has the obligation to “ensure” the product compliance. This means that the importer must have the knowledge about the applicable rules and procedures. It also means that the importer must actively check the documentation, as well as the product. Importers that place on the market non-compliant products may be prosecuted.
What can importers do to comply with their legal obligation to check product conformity? What means does the importer have to detect possible non-compliance?
Join our FREE Webinar, CE Marking: How You Can Check If Suppliers’ Products Comply on the 13th of March 2014 at 16:00 (GMT+01).
Have you been struggling with the question what information has to be included in the EC Declaration of Conformity? And in what format the document should be? Have you been searching for the CE marking logo to put on your product? This package provides you an easy editable template of the Declaration of Conformity in the correct format. And we included the CE logo in various graphical file formats. A download link for the package is delivered immediately upon order. In 5 minutes you’ll be ready. And you’re sure that your template is correct and complete.
Looking for CE Marking a medical device? The process starts with reading the Medical Devices Directive (93/42/EC) and by applying the requirements written there. This can be a tedious process, because the text of the Medical Devices Directive has been amended several times. For your convenience we have a compiled a kit of important documents that you require in order to CE Mark medical devices.
At the very core of the CE marking for machinery is the risk assessment. Manufacturers are allowed to do the risk assessment themselves. It is even highly recommendable to do it, because it provides for a excellent insight in the safety level of the machinery. But how to conduct the risk assessment? The Risk Assessment Guide explains a standardized methodology for hazard identification and risk analysis and risk evaluation. This methodology is very practical: it is used by our own experts. The Guide also includes the checklist for the hazard identification, and a template to record the risk analysis and evaluation. As a bonus, you’ll receive a copy of the standard for risk assessment for machinery, the EN 14121-1.
The CE MasterMind Club is for everyone who wants an easy way to stay abreast of regulatory developments, and at the same time value the opportunity to receive and give feedback in a community of like-minded people. Members enjoy the following benefits:
Peace of mind of being always well informed about your regulatory responsibilities and the latest developments.
No longer waste hours and hours on the internet trying to find bits and pieces of information. In the member Library you can download all directives texts, guidance documents, the most recent lists of standards and more. And a few times per year we’ll send you a copy of the updated Library on a CD-Rom.
Get inside information, tips and tricks from the experts at our special member webinars and round-tables. As a member, you can participate for free. You also get first opportunity to register for general events, so you’re guaranteed to always have one of the best seats.
CE marking can be a difficult and lonely job if you have nobody to turn to. Step into a community of like-minded people. In our MasterMind Club forums you can ask all your questions and get feedback and learn from experiences from other members.
Get access to loads of inspirational articles, audio and video material, reports etc.
Most CE regulations require you to keep your product’s Technical File in Europe, or to appoint a person who you authorize to compile the Technical File when the authorities request.You may choose to give the Technical File to one of your European distributors. However, many manufactures do not prefer to give the Technical File to their distributors, because it contains a lot of confidential design and manufacturing documentation they do not want to disclose to the distributor. Also, many manufacturers want the keep the flexibility to change a distributor. And the distributor may be excellent in selling, but does he have the required knowledge and experience with regulatory affairs? Like many manufacturers, you can choose to appoint an Authorized Representative to retain your Technical Files and handle the requests from the European authorities.
Choose your Authorized Representative wisely. You don’t want to end up with a cheap, one day company that disappears when you need it the most. Search for a reliable regulatory expert with experience in your field.
Click ‘Continue’ to read why our Authorized Representative service is an excellent choice.
Are you losing money because you don’t know how the CE certification works? Have you searched on the internet, but did you get frustrated by the superficial and scattered information? I feel your pain. In fact, it was the reason to set up this website and this free course:
Get Started with CE Marking. Today!
I developed this course for you to better understand CE marking and how it affects your products. The course material is completely made available on-line. So no traveling is required. You can access the course whenever it is convenient for you. You do not need to be available on certain days and times. Take this course and you’ll have a complete overview of what CE marking and CE certification entails, and what you need to do to get it for your products. And just to be absolutely clear: this course is free of charge, and there are no hidden costs or obligations.
What’s the catch?
People often ask me why I give so much valuable information free on this website. My answer is simple. In my time working in CE marking I’ve met some fantastic people, and I have learned a great deal from them. And I could never give back. This is my way of Giving Forward.
Which is why the articles on the website, as well as in my CE marking newsletter, will be extremely comprehensive, but always free. I have other information products, courses and workshops that you may like to buy to get up to speed or to deepen your knowledge, but the free articles will always be FREE.
If you doubt it, even for a moment, read this testimonials and the many others on this website from readers just like you. This will alleviate your fear about having to browse through yet another website.
“I thought the course was absolutely fantastic; informative, easy to understand and very thorough, broken down into manageable sections – all in all I can’t quite believe it has actually been free and thus far catch free!” Lawrence Hill, Marine Entertainment Systems, UK
“The best feature of the mini course is the way it is delivered. When it is broken down into steps that are clear and easily understood with lessons spaced a day apart, I find the mini course allows me to absorb and retain the information much better than trying to absorb it all at once. At first, I thought the presentation would be a sales pitch without much usable information. Now I know that is not true, and would consider the services you offer. I would recommend the mini course to anyone with a product they want to CE certify.” Stephen Cole, RJE International Inc., United States
“I can see that you put a lot of time and effort into the material that you have provided. It is evident that you are both experienced and passionate about your service. I thought the course was absolutely GREAT! The video is well produced and I find that it heightens my interest and thus retention of information. When I started, I must admit, I wondered how you would take such a complex topic and simplify it, so one could gain a good understanding. As I mentioned, the videos especially helped me to gain that understanding by providing a clear and concise overview of what is involved. Thank you very much for this valuable information deliver in a very timely fashion. I definitely recommend this course to anyone interested in learning about CE compliance.” Thomas W. Kaufmann, Technical Publications Specialist, USA
“Yes, your mini-course is very well done, very professional. I liked it a lot. What struck me the most is how you boiled down a seemingly complex issue into very simple terms, easy to understand. My perceptions before even linking to your site was that CE was going to be very time consuming, expensive and take considerable time to obtain. Now I have a better basic understanding of the process and the requirements, plus knowing that we could self certify, makes everything not a mystery. I definitely would recommend to anyone who is delving into CE for the first time. Thanks so much! George Zach, Watertronics LLC, USA
Four reasons why you should subscribe to the free mini course newsletter?
Reason 1: After the mini course you’ll understand the CE marking process and you’ll know what to do next. Reason 2: Only a few articles are open for public viewing. The rest are hidden from view. You will get the direct link in the newsletter I send you. There’s no password. You can’t find the hidden pages on your own. So, without the link in the newsletter, you miss out on some very valuable information. Reason 3: There are dozens of testimonials for our information. People before you have tested it and found it to be extremely good value. Reason 4: It is FREE of charge and there are no hidden obligations. Guaranteed. Bonus: Sign up today, and you will get a FREE powerful e-book with your subscription.
What the free e-book is about
Do you want stop wasting time and money on CE certification, and dramatically improve your CE approval success rate? Is your next CE marking project going to be a huge waste of money? Do you know enough about the CE certification to ensure this never happens? Read this ebook and reduce your CE costs with and dramatically improve your CE success rate.
What happens after you submit the form?
1. You’ll receive an email asking you to confirm you want to sign up and that we have permission to send you information. 2. You’ll receive a user name and password, which you’ll need to login to the website and get access to the course and goodies; 3. Login to the website and from the dashboard click though to the course. Here you’ll also find the goodies. 4. View the video tutorials and read the articles.
Bonus I: As a bonus for taking my course, you’ll receive my CE Marking Newsletter so you can stay informed about changes in CE marking regulations and standards. Bonus II: You also get a copy of the powerful E-book ’10 Clues About CE 3rd Parties Don’t Want You To Know’. You can download it from the Dashboard right after you login.
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“Hello Han….the course was fabulous. It was very well organized and easy to follow. CE marking for those of us in North America is somewhat of a mystery. The course definitely addressed the knowledge gaps which I had regarding CE marking. I would recommend your course to my colleagues.” Jeff Stonos, BTI Systems, USA
“I found your course very informative , clear and logical. Your course is the best I have come across especially the part on Directives and Standards. Unlike those articles given by well known laboratories, they tend to lead readers that the they are the only ones that you must use before you can declare conformity of CE. I will definitely recommend your website to all those people involved directly and indirectly in CE. Well done!” Danny Chung