- February 19, 2018
- Posted by: admin
- Category: CE Certification, CE Marking, Certification, Product Certification
What is CE marking? What are the Product Directives? Which countries require CE marking? What products are covered by the CE marking requirement? How do I check my product is CE marked?
EU-CERTis a Notified Body under 20 EU Directives relating to CE marking Certification and 1 Regulation, CE marking services from EU-CERT – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body.
As a Notified Body, EU-CERT can help you gain access to the European market by ensuring your product meets all CE marking requirements.
What is CE Marking or CE Certification?
The CE Marking Certification is a key indicator but not proof of an Equipment compliance with European Union EU health, safety and environmental protection directives and regulations.
If your Equipment comes under the scope of a directive requiring CE Certification you must ensure the Equipment complies with the applicable requirements and affix the CE Marking before placing it in the market in the European Economic Area EEA see Countries In Which The CE Certification Is mandatory below for a description of the countries that are included in the EEA. This is equally valid if your Equipment is manufactured outside the EEA. Secondhand Equipment from outside the EEA that are placed in the EEA market for the first time also require CE Certification.
Frequently the CE Marking Certification is called as a trade passport because it enables the free movement of Equipment 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 Equipment, unless such measures can be confirmed on the basis of proof of the non-compliance of the Equipment. CE Mark Certification does not indicate that Equipment was made in the EU European Union. The CE Marking also is not a quality marking.
- You cannot affix the CE Marking Certificate to Equipment which are not covered by the relevant European directives,
- By affixing the CE Mark Certificate, you take full responsibility for your Equipment compliance with the requirements of the relevant directives,
- Other markings may be affixed to the Equipment as long as those markings do not create confusion with the CE Mark Certificate in form or meaning.
The form of the CE Marking Certificate
The CE Certification is a marking that consists of the initials ‘CE’ in the following form:
There are no particular color requirements for the letters and background of the CE Marking Certification. In other words, it is not Needs to print the letters ‘CE’ in black against a white background. However, the color schemes for the foreground and background should be sufficiently complementary, so that the CE Mark logo is without any doubt clearly visible. The minimum dimension of the CE Marking must be 5 mm in height. If the size is enlarged, the letters CE must be in proportion to the standard version as shown. Please find here example of the CE Mark logo in different file formats: http://ec.europa.eu/enterprise/faq/ce-mark.htm The CE Marking sometimes is accompanied by a 4 digit number. This is a reference number of the (NB) Notified Body that has been involved in the conformity assessment method.
Equipment that needs CE marking Certification
Equipment that requires being CE marked are:
- Household refrigerators and freezers
- Energy-related products
- Active implantable medical devices
- Electronics and active components
- Appliances burning gaseous fuels (gas appliances)
- Cableway installations designed to carry persons
- Equipment and protective systems intended for use in potentially explosive atmospheres (ATEX equipment)
- Explosives for civil uses
- Hot-water boilers
- In vitro diagnostic medical devices
- Low voltage equipment (electrical material)
CE Mark Certificate is not required for items, for example:
- Medical devices
- Outdoor equipment producing noise
- Pressure equipment
- Measuring instruments
- Non-automatic weighing instruments
- Personal protective equipment
- Simple pressure vessels
- Radio and telecommunications terminal equipment
- Recreational craft
Countries in which the CE Certification is required?
The CE Certification is affixed to the aforementioned Equipment that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.
CE Marking Certification is currently required in 31 countries:
- Czech Republic
- The Netherlands
- United Kingdom (Great Britain)
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.
What are the Responsibilities for CE Mark Certification?
Persons that bear a responsibility for CE Marking and the CE compliance of Equipment are:
- Authorized 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 Marking to the Equipment
If you are the importer Equipment from a third country you have to check that the manufacturer outside the EU has undertaken the mandatory steps. You must check that the documentation is ready for use. However, if you import the Equipment 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 Marking Certification and the user manual, Equipment label, and other mandatory supporting documentation.
How to get the CE Marking Certificate?
Despite what many persons believe, a manufacturer does not get the CE Marking from a third party certification body or a European or national authority. The manufacturer affixes the CE Certification 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 method 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 Mark Certification rules typically require the following steps to be fulfilled before the CE Marking may be affixed:
- Determine the applicable CE directives/regulations; you can use the CE Directive Checklist in our CE Certification
- Identify the applicable European harmonized standards.
- Identify which essential requirements of the CE Mark Certification directive/regulations apply to the Equipment.
- Identify which requirements of the European harmonized standards apply to the Equipment.
- Conduct and document the conformity assessment against the essential requirements and the requirements of the standards, this may entail visual inspection, testing etc.
- Machinery and medical devices require being submitted to a risk analysis.
- Provide the user with the information needs to use the Equipment safely typically user manual, installation instruction, warning labels etc.
- Ensure consistency of production, thus proving the assessed sample and the production are identical.
- Compile a Technical File or sometimes called technical documentation of all documents that are mandatory to show compliance with all relevant requirements.
- Draw up and sign a Declaration of Conformity for construction Equipment a Declaration of Performance.
- Affix the CE Marking.
- Continuously monitor improvement relevant to CE directives/regulations and European harmonized standards. Apply new rules and amendments where appropriate.
Enforcement of CE Certification and sanctions
As indicated, Equipment with that bear the CE Marking have a free access to the market in the sense that the authorities are not allowed to require all kinds of needs to be fulfilled. However, that does not mean that the authorities have no right to investigate the Equipment compliance. Not only can they investigate, but they can also take measures against infringements. These measures may include withdrawal, recall of Equipment, penalties and criminal sanctions such as fines and imprisonment wherever mandatory.
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 Equipment, 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.
CE Marking directives and regulations:
Here is an overview of the main CE Certification directives. The links will take you to a page with information about the specific directive.
- ATEX Directive – 2014/34/EU
- Active Implantable Medical Devices Directive – 90/385/EEC
- Construction Products Regulation – Regulation (EU) No 305/2011
- EMC Directive – 2014/30/EU
- Explosive for Civil Use Directive – 93/15/EEC
- Gas Appliances Directive – 2009/142/EC
- Low Voltage Directive – 2014/35/EU
- Lifts Directive – 1995/16/EC
- Machinery Directive – 2006/42/EC
- Measuring Instruments Directive – 2004/22/EC
- Medical devises Directive – 93/42/EEC
- Noise Emission in the Environment Directive – 2000/14/EC
- Pyrotechnic Directive – 2007/23/EC
- Personal Protective Equipment Directive – 89/686/EEC
- Pressure Equipment Directive – 2014/68/EU
- RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
- Radio Equipment Directive – 12014/53/EU
- Recreational Craft Directive – 94/25/EC
- Toy Directive – 2009/48/EC
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
If you are Searching for secrets about CE certification, Check Here top 12 secrets about CE marking certification of electrical and electronic products