What is CE marking?
European economic area (EEA) the single market of free product movement. With less bureaucratic product movement restrictions come more risk associated with products placing on the single market of several different countries. In the name of consumer protection uniform rules and regulations has been adopted over EEA member states in order to assure safety of products available on the market.
EEA member states
- Czech Republic
- The Netherlands
- United Kingdom
- (Switzerland – not member- mutual recognition)
- (Turkey – no member – mutual recognition)
CE marking “Conformité Européene” or literally “European Conformity the declaration of producers that the products manufactured and placed on the market under their name and responsibility complies with Essentials requirements laid down by product specific European directives. These letters signify that products placed in the EEA have been assessed to meet safety, health and environmental protection requirements. Once your product meet all applicable legal requirements for CE marking and therefore is able to bear CE marking, European single market is freely open in every single member state of union without any unjustified restrictions and equally is open from manufactures and trade organization around the world without any geographical restrictions.
What does CE marking mean?
CE marking is not mandatory for whole products ranges placed on the market however is still required for wide a range of products from various industry sectors and it demonstrates:
- CE marking shows that the manufacturer has checked and declares the product conformity with European safety, health or environmental requirements defined by European directives, regulations or even may with harmonized standards
- CE marking affix to products assured their free movement within the European market without restrictions
- CE marking is an visual symbol and indicator of a product’s compliance with applicable European regulations
- CE marking is a ticket to European single market or even worldwide markets recognizing CE marking
A sole responsibility of manufacture
- set up the technical file as main objective prove of product conformity with applicable specifications and as one of the basis for conformity assessment process
- carry out the conformity assessment according to applicable conformity assessment routes set by relevant new approach European directive. Is possible self assessment is allowed for specific kind of product, otherwise third party conformity assessment, performed by notified body is required
- draw up the EC Declaration of Conformity (DoC) and obain EC certification as a third party conformity confirmation (if applicable)
CE marking applies to various kind of products, from toys, personal protective equipment, electrical equipment to explosives or medical devices. The list of these product categories is as folows:
- active implantable medical devices
- appliances burning gaseous fuels
- cableway installations designed to carry persons
- energy related products
- electromagnetic compatibility
- equipment and protective systems intended for use in potentially explosive atmospheres
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels
The CE marking is not required for product likes:
- pharmaceuticals, cosmetics and foodstuffs however national regulations may be applied for placing of such products
- 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
How to place a CE marking on products?
At the very beginning to know applicable legal requirements for CE marking is essential in order to understand all mandatory steps and associated obligations prior CE marking. Choose right European new approach directive and conformity assessment route, which fit to your needs and as well meet binding legal aspects. The process you will follow depends on the directive that applies to your product.
1.Know legal requirements, regulations and applicable directive
There are more than 20 directives setting out the essential requirements and applicable conformity assessment routes for particular product categories requiring CE marking. These directives are issued by European parliament and council and transposed to national laws and regulations of particular member state. Meeting of European directives should means meeting the national regulations. Despite the European directives there are horizontal and vertical European Standards or Harmonization Documents issued by European standard agencies like CENELEC. Those standards provide common specifications on products which should be followed by manufacturers even there is not binding requirement to follow them during the conformity demonstration and is still possible to show , that your product is as safe, by presenting the relevant documentation. However is generally expected manufactures keening for CE marking will follow Harmonized standards.
2. Interaction of a Notified Body
Each directive covering your product specifies the need of notified body interaction based on the chosen conformity assessment route. In such case when third party independent conformity assessment is required, especially for high risk products, Notified body challenge your product against applicable requirements.
3. Prove safety of your products and keep technical files
As a main part of CE marking process the safety and meeting all applicable requirements on your products shall be demonstrated by objective evidence, like technical files, assessment reports, product testing and other relevant proves. Technical files full of conformity evidence shall be available for authorities during the lifetime of products and even much more longer for specific products as a main conformity evidence. Regular update of technical files shall be performed in order to assure compliance with actual legal requirements and sector state of art.
4. EC Declaration of Conformity and EC certification
The CE marking must be placed on the product by the manufacturer, or by his authorized representative within the EEA or Turkey. It must be placed according to its legal format stated in directive and must be clearly visible, legible and impossible to remove. If a Notified Body was involved in the any of conformity assessment activity it is mandatory the four digits number of notified body follows CE marking. EC declaration of conformity as a main commitment of manufacturer to comply with European requirements shall be drawn up and kept available at any time.
93/42/EEC Medical devices
Medical devices determined by classification rules of European parliament and council directive 93/42/EEC are intended to undergo CE marking proces defined by one of the described conformity assessment routes.
98/79/EC In Vitro diagnostic
In Vitro diagnostic medical devices are regulated by European parliament and council directive 98/79/EC and similary as medical devices directive, defines the conformity assessment routes available for manufacturer`s choice.
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