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CE Marking Basics
In the video in this blog post, we explain what the CE Mark / CE marking / CE certification is, and what it entails:
At cemarking.net you will find information and resources to answer questions like:
- What is CE marking?
- What does the CE mark mean? What do the initials CE stand for?
- Do your products need CE marking?
- How do you benefit from CE marking??
- In which countries is the CE marking required?
- How do I CE mark my product?
- Do our products automatically qualify for the CE mark when they are UL/CSA approved?
- Who should undertake CE marking?
- Notified Bodies: What Are They? What Is Their Role
- What is the CE marking process?
- What files / documentation must I keep?
- How and where must the CE mark appear?
- Other Posts About CE Marking
As well as information and explanations about CE marking related requirements such as:
- Essential requirements
- Conformity assessment
- Notified Bodies
- Technical File
- Declaration of Conformity
- Declaration of Incorporation
- User instructions
How Can I Get The CE Mark?Despite what many people believe, a manufacture does not “get” the CE mark from a third party certification body or a European or national authority. The manufacturer affixes the CE marking in his own right and is allowed to do so when all requirements are fulfilled. A test or certification body may be involved in the process merely as a service provider. However, the body will not take over responsibility for CE compliance. Responsibility for CE compliance will always remain with the manufacturer (or private labeler).
The CE marking rules typically require the following steps to be fulfilled before the CE mark may be affixed:
Frequently Asked Questions About CE Marking:
What does the CE marking on a product indicate?
By affixing the CE marking to a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.
Is a product affixed with the CE marking always produced in the EU?
No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.
Are all CE marked products tested and approved by authorities?
No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.
What are the sanctions for counterfeiting the CE marking?
The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.
Where should the CE marking be affixed?
The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.
Who supervises the correct use of the CE marking?
In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.
CE Marking DirectivesHere is an overview of the main CE marking directives. The links will take you to a page with information about the specific directive.
- Pyrotechnic Directive - 2007/23/EC
- Machinery Directive - 2006/42/EC
- Low Voltage Directive - 2014/35/EU
- EMC Directive - 2014/30/EU
- Medical Devices Directive - 93/42/EEC
- Personal Protective Equipment Directive - 89/686/EEC
- Construction Products Regulation - Regulation (EU) No 305/2011
- Pressure Equipment Directive - 97/23/EC
- REACH - Regulation (EC) No 1907/2006
- RoHS – Restriction of Hazardous Substances – Directive - 2011/65/EU
- Waste Electrical and Electronic Equipment Directive (2012/19/EU) - 2012/19/EU
- ATEX Directive (2014/34/EU) - 2014/34/EU
- Toy Safety Directive (2009/48/EC) - 2009/48/EC
- R&TTE Directive (1999/5/EC) - 1999/5/EC
- Recreational Craft Directive (94/25/EC) - 94/25/EC
- Active Implantable Medical Devices Directive - 90/385/EEC
- Noise Emission in the Environment Directive - 2000/14/EC
- Gas Appliances Directive - 2009/142/EC
“At first I hesitated to do CE self-certification, because I wasn’t sure I would be able to do it. Your system provides the templates and instructions to certify CE compliance. And with what I learned I was able to complete the CE marking within one week. It was a good investment. Your support and customer service are excellent!”Tatiana Batache, SkateRunner, Belgium