Be a benchmark
ISO 9001:2008 (Quality Management System) ISO 14001:2004 (Environment Management System) ISO 18001:2007 (Occupational Health & Safety Management System) ISO 22000:2005 (Food System Management System) ISO 13485:2003 (Medical Device System) EN 16001 (Energy Management) ISO 27001:2005 (Information Security Management System) TS-1649 (Quality Management System For Automotive Suppliers)
Services
CE MARK

What is CE Marking (CE Mark)?
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in 1993. "CE Marking" is now used in all EU official documents.

  1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product directives.
  2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
  3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
  4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

General principles of the CE marking

  1. The CE marking shall be affixed only by the manufacturer or his authorised representative.
  2. The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
  3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
  4. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.
  5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
  6. Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

Does my product need CE Marking?
CE Marking is most probably required if you export to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states the
following 20 groups of products -

  1. Appliances Burning Gaseous Fuels (AppliGas) 
    The "appliances burning gaseous fuels" used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 gC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances.
    The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar. 
  2. Cableway Installations to Carry Persons 
    The "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.
    These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel. 
  3. Low Voltage Electrical Equipment
    The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use.
  4. Construction Products 
    The "construction product" means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. 
  5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
    • Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
    • Protective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
    • Components means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
      Potentially explosive atmosphere means an atmosphere which could become explosive due to local and operational conditions.
  6. Explosives for Civil Uses
    The "Explosives" here shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations. 
  7. Hot Water Boilers 
    The "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including 4 kW and 400 kW). 
  8. Lift
    The "lift" here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:
       - persons,
       - persons and goods,
       - goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. 
  9. Machinery 
    the "machinery" means:
    • an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,
    • an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
    • interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool.
  10. Measuring Instruments 
    the "measuring instrument" means: any device or system with a measurement function that is covered by Articles 1 and 3; 
  11. Medical Devices 
    A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of : 
    • diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap. 
    • investigation, replacement or modification of the anatomy or of a physiological process. 
    • control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. 
  12. Active Implantable Medical Devices
    The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
    The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
  13. In Vitro Diagnostic Medical Devices 
    The "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
        - concerning a physiological or pathological state, or
        - concerning a congenital abnormality, or
        - to determine the safety and compatibility with potential recipients, or
        - to monitor therapeutic measures..
  14. Non-automatic Weighing Instruments 
    A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics. 
    A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing. 
  15. Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
    A "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication.

    A "telecommunications terminal equipment" means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services).
  16. Personal Protective Equipment (PPE) 
    The "personal protective equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. 
  17. Simple Pressure Vessels 
    The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired. 
  18. Pressure Equipment 
    The "Pressure Equipment" means vessels, piping, safety accessories and pressure accessories.
    Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
    'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.
    'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.
    'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:
       - devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and
       - limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)` devices.
    'Pressure accessories` means devices with an operational function and having pressure-bearing housings.
    'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.
  19. Recreational Craft
    The "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes. 
  20. Toys 
    A "toy" shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age. 
How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product? 

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents: 

  1. Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
  2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s). 
  3. Choose the conformity assessment procedure from the options (Modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:
    Module A: internal production control
    Module A1: intervention of a Notified Body
    Module B: EC type-examination
    Module C: conformity to type
    Module D: production quality assurance
    Module E: product quality assurance
    Module F: product verification
    Module G: unit verification
    Module H: full quality assurance 

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called “Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking. 

Minimal Risk

Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product. 

Greater Risks

Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union.

A Notified Body is usually able to offer some of the services required:

  • product testing
  • type examination certificate issue
  • Technical File and design dossier evaluation
  • surveillance of product and quality system
  • identification of standards

If your products need to be certified by a Notified Body, then you will need to do as the follows:

  1. Select the applicable product standards and test methods for your product and select a Notified Body.
  2. Establish a Representative in the European Union for your product.
    Some directives require that a manufacturer designate in the European Union an authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities.
    Technical Documentation (Technical File): The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
  3. Prepare a Declaration of Conformity. 
    The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. It may include a list the directives and standards that your product conforms to, product identification, the manufacturer's name, address and signature.
  4. Register your product in EU
    Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market. 
  5. Affix the CE Marking to your product. 
    There are specific rules to adhere to for the CE Marking. These rules address the size and location of the Marking; affixing the CE Marking to products, packaging and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the CE Marking.