“This system you have is very good and I am so glad we are able to work with you on our CE compliance.”
– Luke Vazul, KHS, USA
1.Determine which CE Rules apply
Determine which European regulations and standards apply to your products.
2.Assess the CE Conformity
Find out how to do demonstrate CE compliance yourself, and how to leverage your suppliers’ CE certificates.
3.Grow your business
Get CE marking, get access to the European market and grow your business.
What makes CE Marking with us so different?
When it comes to CE marking, there are many service providers out there that want to sell their consulting, testing and certification services. Our ‘Six Step CE Marking Framework’ helps companies to take control of the CE marking process, reduce the costs and reach results fast. In six steps, our clients determine the applicable CE rules, self-certify the conformity, prepare the required and stay informed about regulatory changes.
Our framework can be tailored to your specific needs. We offer personal consulting and coaching, online workshops and tools. Hundreds of companies have grown their businesses by using our Six‑Step CE Marking Framework.
Conduct CE self-certification with our Six Step Framework and Coaching
CE Marking Quick Guide
The CE marking is a key indicator (but not proof) of a product’s compliance with European Union (EU) health, safety and environmental protection directives and regulations.
If your product comes under the scope of a directive requiring CE marking you must ensure the product complies with the applicable requirements and affix the CE mark before placing it in the market in the European Economic Area (EEA) (see “Countries In Which The CE Marking Is Required” below for a description of the countries that are included in the EEA). This is equally valid if your product is manufactured outside the EEA. Second hand products from outside the EEA that are placed in the EEA market for the first time, also require CE marking.
Often the CE marking is described as a trade passport because it enables the free movement of products within the European market. According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark.
- active implantable medical devices
- appliances burning gaseous fuels (gas appliances)
- cableway installations designed to carry persons
- energy related products
- electronics and active components
- equipment and protective systems intended for use in potentially explosive atmospheres (ATEX equipment)
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage equipment (electrical material)
- measuring instruments
- medical devices
- outdoor equipment producing noise
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- simple pressure vessels
The CE marking is not required for items, for example:
The CE marking is affixed on the aforementioned products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.
The CE marking is currently required in the following countries:
- Austria (since 1995)
- Bulgaria (since 2007)
- Czech Republic (since 2004)
- Cyprus (since 2004)
- Estonia (since 2004)
- Finland (since 1995)
- Hungary (since 2004)
- Latvia (since 2004)
- Lithuania (since 2004)
- Malta (since 2004)
- The Netherlands
- Poland (since 2004)
- Romania (since 2007)
- Slovakia (since 2004)
- Slovenia (since 2004)
- Sweden (since 1995)
- United Kingdom (Great Britain)
- Croatia (since July 1, 2013)
Switzerland is not a member of the European Union, but for some products it accepts the CE marking as a presumption of conformity with Swiss national technical regulations.
Persons that bear a responsibility for CE and the CE compliance of products are:
- manufacturer (irrespective if located in our outside the EEA)
- authorised representative
If you are a manufacturer it is your responsibility to:
- carry out the conformity assessment
- draw up the Technical File
- issue the EC Declaration of Conformity (DoC)
- affix the CE mark to the product
If you are the importer a product from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available. However, if you import the product but place it in the EU market under your own (brand)name, you have the same obligations as the manufacturer.
If you are a distributor you must check the presence of both the CE mark and the user manual, product label and other necessary supporting documentation.
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:
As indicated, products with that bear the CE mark have a free access to the market in the sense that the authorities are not allowed to require all kinds of requirements to be fulfilled. However, that does not mean that the authorities have no right to investigate the product’s compliance. Not only can they investigate, but they can also take measures against infringements. These measures may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.
Please note that there is not a single, European Union enforcement agency or service. Enforcement of CE legislation is performed by national market surveillance authorities, in accordance with the national laws and procedures of the Member States of the EU. These national market surveillance authorities work together closely, sharing information about non-compliant and unsafe products, as well as coordinating their market surveillance campaigns. If a non-compliant CE marked product is discovered in one market, all the other market surveillance authorities will be informed about it by the next morning.
- 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 – 2014/68/EU
- RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
- ATEX Directive – 2014/34/EU
- Toy Directive – 2009/48/EC
- Radio Equipment Directive – 12014/53/EU
- Recreational Craft Directive – 94/25/EC
- Active Implantable Medical Devices Directive – 90/385/EEC
- Explosive for Civil Use Directive – 93/15/EEC
- Noise Emission in the Environment Directive – 2000/14/EC
- Gas Appliances Directive – 2009/142/EC
- Lifts Directive – 1995/16/EC
- Pyrotechnic Directive – 2007/23/EC
- Measuring Instruments Directive – 2004/22/EC
- 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?
- What does CE certification cost?
- 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:
Frequently Asked Questions About CE Marking
– Rick Booth, DMS, United Kingdom
Start CE Marking Today
End the confusion. Get a clear roadmap for the CE marking process. Our ‘Six Step CE Marking’-framework helps you take control of the CE marking process and reach results fast. Click the ‘Start Now’-button below, fill out the form and we’ll advise you what solution will best fit your needs.