CE MARKING

CE marking is the manufacturer's claim that the product meets the essential requirements of relevant EU Directives & Standards applicable to their product. CE marking is a legal requirement for many products sold throughout the 25 nations of the European Union and the 3 states of the European Free Trade Association that makes the European Economic Area. CE marking also referred to as "CE Mark" or "CE-Marking", is a mandatory mark for many of the products circulated on the EFTA & European Union (EU) single market (28 countries) and is often referred to as a Trade Passport to Europe. CE marking obtained from one EU country is valid for the entire EU plus EFTA market. Any product that falls under a European New Approach Directive and is placed on the market in the European Economic Area (EEA) must bear CE marking.
The letters "CE' are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". CE marking as a term was officially "launched" by the CE Marking Directive, 93/68/EEC, in 1993. CE marking is now used in EU official documents.

The European Economic Area includes Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom (UK) plus, since 1st May 2004, when they became part of the European Union, Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia.

The responsibility to affix these markings is with the manufacturer. It is illegal to apply the CE marking if conformity with the requirements has not been established or to use other markings, which may be confused with the CE marking. An example of the CE mark where there has been no Notified Body involvement is:

In cases where a Notified Body has involvement in the conformity assessment process, the identification number of the Notified Body must be affixed to the product alongside the CE marking.

Harmonised standards

In order to assist the manufacturer (or importer) with the conformity assessment of a product, standards which apply across the EEA are being drafted at a relatively high rate. They are known as harmonized standards and can be recognize as such by the indication EN before the standard number.

Many of these standards make it possible to do without an extensive risk analysis. By adhering closely to the articles of the standard it can be assumed that there is a ‘presumption of conformity’ with the relevant EC directives. In contrast to the EC directives the standards are very technical. Standards can be much more easily adapted to take account of current technical developments. EN-standards are not mandatory but often serve as a very useful tool.

Product liability

Since the introduction of CE marking product liability in a European framework has become much more strictly controlled in order to avoid an 'American situation'. There is a separate directive which only applies only to products which do not meet the essential requirements.

It is now up to the manufacturer, or his representative, to demonstrate that things are in order on delivery. In order to receive compensation the victim must be able to prove that the damage was caused by the product. However, he does not have to prove that the manufacturer has been negligent.

Applying CE -marking

The CE marks are applied by the manufacturer or the importer for the EEA.

The CE logo should be clearly visible on the product (or on the packaging if there is no space on the product). In conjunction with the EC declaration of conformity the manufacturer is stating here that the product meets the requirements of the EC directives for CE marking. These are usually New Approach directives, but there are also a few other directives that affect CE marking, such as some of the Global Approach directives.

Principles of CE marking

• The CE marking symbolizes the conformity of the product with the applicable Community requirements imposed on the manufacturer.
• The CE marking affixed to products is a declaration by the person responsible that:
• the product conforms to all applicable Community provisions,
• and the appropriate conformity assessment procedures have been completed.

CE marking symbolises conformity to all the obligations incumbent on manufacturers for the product by virtue of the Community directives providing for its affixing. When affixed to products it is a declaration by the natural or legal person having affixed or been responsible for the affixing of CE marking that the product conforms to all applicable provisions, and that it has been subject to the appropriate conformity assessment procedures. Hence, Member States are not allowed to restrict the placing on the market and putting into service of CE marked products, unless such measures can be justified on the basis of evidence of the noncompliance of the product (121). The directives providing for the affixing of the CE marking mostly follow the principles of the New Approach and the Global Approach, but this is in itself irrelevant for the application of the CE marking. In fact, CE marking can be introduced in Community legislation as legal conformity marking if:

• the method of total harmonisation is used, which means that diverging national regulations that cover the same public interests as the directive are prohibited;and
• the directive contains conformity assessment procedures according to Decision 93/465/EEC (122).

As a general rule, all New Approach directives provide for the affixing of the CE marking. In duly justified cases a total harmonisation directive that follows Decision 93/465/EEC may provide for a different marking instead of the CE marking (123). Since all products covered by New Approach directives bear CE marking, this marking is not intended to serve commercial purposes. Neither is the CE marking a mark of origin, as it does not indicate that the product was manufactured in the Community.

Products to be CE marked

• The CE marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service, save where specific directives require otherwise.
• Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives.
• A product may not be CE marked, unless it is covered by a directive providing for its affixing.

The obligation to affix the CE marking extends to all products within the scope of directives providing for its affixing, and which are intended for the Community market . Thus, the CE marking must be affixed:

• to all new products, whether manufactured in the Member States or in third countries;
• to used and second-hand products imported from third countries; and
• to substantially modified products that are subject to directives as new products.

Directives may exclude the application of the CE marking on certain products, even if the directive otherwise applies to the product. As a general rule, such products are subject to free circulation if:

• they are accompanied by a declaration of conformity (as is the case for safety components referred to in the Directive on machinery and partly completed boats referred to in the Directive on recreational craft);
• they are accompanied by a declaration of compliance (as is the case for products playing a minor part with respect to the health and safety listed in accordance with the Directive on construction products);
• they are accompanied by a statement (as is the case for custom-made medical devices and devices intended for clinical investigations referred to in the Directives on active implantable medical devices and medical devices, and devices intended for performance evaluation referred to in the Directive on in vitro diagnostic medical devices);
• they are accompanied by a certificate of conformity (as is the case for components referred to in the Directive relating to potentially explosives atmospheres which are intended to be incorporated into equipment or protective systems, and fittings referred to in the Directive relating to gas appliances);
• the product bears the manufacturer’s name and an indication of maximum capacity (as is the case for instruments not subject to conformity assessment according to the Directive relating to non-automatic weighing instruments); or
• the product is manufactured in accordance with sound engineering practice (as is the case for certain vessels referred to in the Directives relating to simple pressure vessels and pressure equipment).

During the transitional period of a directive the manufacturer usually has the choice to either meet the requirements of the directive or the relevant national regulations. The option chosen and, hence, the extent of the conformity expression enshrined in the CE marking shall be clarified by the manufacturer in the EC declaration of conformity, and in the documents, notices or instructions accompanying the product .

Affixing of the CE marking

The CE marking must be affixed by the manufacturer, or by the authorised representative established within the Community. The CE marking must take the form below. If the CE marking is reduced or enlarged the proportions must be respected.

The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.

Where a notified body is involved in the production control phase according to the applicable directives, its identification number must follow the CE marking. The manufacturer or the authorised representative established in the Community affixes the identification number, under the responsibility of the notified body.

The CE Marking Process

Step 1: Identify the directive(s) that are applicable to your product. You can download these directives free of charge from European Union website . How ever one or more directive may apply to the product.

Step 2: Identify the conformity assessment procedure that must be taken.  This could be self-certification or involve inspection or testing from a Notified Body.  The conformity assessment procedure will differ depending on your product and the Directive to which you are CE Marking. 

Step 3: Determine the dates by which you must take action.    The majority of directives are in force.  In these cases it is an offence to place a product on the market without CE Marking.

Step 4: Identify if there are any Harmonized European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption of conformity to these standards. The European Directives require that whenever possible or appropriate, manufacturers should follow harmonized standards 

Step 5: Ensure the product complies with the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

Step 6: Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the directive and is dependent upon the product you are CE Marking.  

Step 7: Maintain Technical Documentation required by the Directive(s).  Your technical documentation should support your compliance with the requirements of the Directive.

Step 8: Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request. 

Step 9: Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labeling or packaging requirements.

Step 10: Apply CE Marking on your product and/or it’s packaging and accompanying literature as stated in the directive.

Obtaining CE Marking for your product can be an extremely long, complex and confusing process, but with the help of a Notified Body, it need not be overwhelming. 

EXAMPLES OF FEW DIRECTIVES

• Acoustic properties of building products and of buildings
• Acoustics
• Adhesives
• Aggregates
• Aluminium and aluminium alloys
• Cast iron pipes, fittings and their joints
• Cement and building limes
• Ceramic tiles
• Chimneys
• Concrete and related products
• Concrete reinforcing and prestressing steels
• Copper and copper alloys
• Doors, windows, shutters, building hardware and curtain walling
• Durability of wood and derived materials
• Elastomeric seals for joints in pipework and pipelines
• Fire detection and fire alarm systems
• Fire safety in buildings
• Fire service equipment
• Fixed firefighting systems
• Flanges and their joints
• Flanges and their joints
• Floor screeds and in-situ floorings in buildings
• Foundry technology
• Free-standing industrial chimneys
• Gas pressure regulators for use in gas transmission and distribution
• Geosynthetics
• Glass in building
• Gypsum and gypsum based products
• Heat exchangers
• Industrial valves
• Lighting columns and spigots
• ] Masonry
• Materials
• Natural stones
• Paints and varnishes
• Paving units and kerbs
• Pigments and extenders
• Plastics
• Plastics piping systems and ducting systems
• Precast concrete products
• Prefabricated reinforced components of autoclaved aerated concrete
• Railway applications
• Raised access floors
• Refractory products and materials
• Resilient, textile and laminate floor coverings
• Road equipment
• Road materials
• Roof covering products for discontinuous laying and products for wall cladding
• Round and sawn timber
• Rubber and plastics hoses and hose assemblies
• Sanitary appliances
• Steel - Mechanical testing
• Steel castings
• Steel tubes and fittings for steel tubes
• Steel wires
• Steels - Definition and classification
• Steels for heat treatment, alloy steels and free-cutting steels
• Structural bearings
• Structural Eurocodes
• Structural steel sections and hot rolled steel bars for engineering use
• Structural steels - Grades and qualities
• Surface coated flat products - Qualities, dimensions, tolerances and specific tests
• Suspended ceilings
• Technical conditions of delivery and quality control
• Thermal insulating materials and products
• Thermal performance of buildings and building components
• Threaded and non-threaded mechanical fasteners and accessories
• Timber structures
• Transportable gas cylinders
• Unfired pressure vessels
• Ventilation for buildings
• Wall coverings
• Waste water engineering
• Water supply
• Welding
• Wire-rod - Qualities, dimensions, tolerances and specific tests
• Wood-based panels

• Alarm systems
• Automatic controls for household use
• BROADCASTING Broadcasting, TV, audio
• Cable networks for television signals, sound signals and interactive services
• Circuit breakers and similar devices for household and similar applications
• Communication, signalling and processing systems
• Construction equipment and building material machines – Safety
• DECT Digital Enhanced Cordless Telecommunications
• Devices
• Doors, windows, shutters, building hardware and curtain walling
• DRRS Digital Radio Relay System
• DRRS Digital Radio Relay System]
• Electric resistance welding
• Electric supply and earthing systems for public transport equipment and ancillary apparatus (Fixed installations)
• Electrical accessories
• Electrical and electronic applications for railways
• Electrical apparatus for detection and measurement of combustible gases to be used in industrial and commercial potentially explosive atmospheres
• Electromagnetic Compatibility (EMC)
• Electromechanical material on board rolling stock
• EMC Electro-Magnetic Compatibility
• EMC products
• Equipment for electrical energy measurement and load control
• FWA Fixed Wireless Access (cf RLL, WLL, FRA)
• GMDSS Global Maritime Distress and Safety System
• GSM Global System for Mobile communications
• HIPERLAN High Performance Radio Local Area Networks (LAN)
• Home and Building Electronic Systems (HBES)
• Industrial Trucks – Safety
• Low-voltage switchgear and controlgear assemblies
• Low-voltage switchgear and controlgear including dimensional standardization
• Luminaires and associated equipment
• Mains communicating systems
• Maritime navigation and radio communication equipment and systems
• Measuring relays and protection equipment
• Passenger, goods and service lifts
• PMR Private Mobile Radio
• Power electronics
• Power system control and associated communications
• RADIO
• Relays
• Road traffic signal systems
• Rotating machinery
• Safety of machinery: electro technical aspects
• Safety of measuring, control, and laboratory equipment
• SATELLITE (Cf terrestrial, aeronautical, maritime)
• SHORT RANGE (radio)
• Small power transformers, reactors, supply units and similar products
• Switches for household and similar fixed electrical installations
• System aspects
• TETRA Terrestrial Trunked Radio system
• Tractors and machinery for agriculture and forestry

• Apparatus type of protection
• Electrical apparatus for detection and measurement of combustible gases to be used in industrial and commercial potentially explosive atmospheres
• Electrical apparatus for explosive atmospheres: General requirements
• Electrostatic painting and finishing equipment
• Equipments for making and shaping of metals - Safety requirements
• Flameproof enclosures d
• Increased safety e
• Industrial thermo processing – Safety
• Industrial Trucks – Safety
• Internal combustion engines
• Intrinsically safe apparatus and systems I
• Packaging machines – Safety
• Potentially explosive atmospheres - Explosion prevention and protection
• Pressurization and other techniques
• Printing and paper machinery – Safety
• Pumps
• Refrigerating systems, safety and environmental requirements
• Safety of machinery
• Shop fabricated metallic tanks & equipment for storage and for service stations
• Surface treatment equipment – Safety

• Chains, ropes, webbing, slings and accessories – Safety
• Passenger, goods and service lifts

• Alarm systems
• Appliance couplers
• Audio, video and multimedia systems and equipment
• Automatic controls for household use
• Automatic operating analytical appliances including In-Vitro-Diagnostic Medical Devices
• Basic and safety principles for man-machine interface, marking and identification
• Cable management
• Cable networks for television signals, sound signals and interactive services
• Circuit breakers and similar devices for household and similar applications
• Connecting devices
• Connectors
• Conversion adaptors for industrial use
• Degrees of protection provided by enclosures
• Devices
• Electric arc welding equipment
• Electric cables
• Electric resistance welding
• Electrical accessories
• Electrical installations and protection against electric shock
• Electrical installations of buildings: Protection against thermal effects
• Electrical systems for electric road vehicles
• Electro acoustics
• Electromagnetic fields in the human environment
• Equipment and tools for live working
• Fire hazard testing
• Gas detectors
• Hearing aids and audiometers
• Home and Building Electronic Systems (HBES)
• Industrial electro heating equipment
• Industrial plugs and socket-outlets
• Insulation co-ordination for low-voltage equipment
• Isolating and safety isolating transformers
• Lamps
• Low-voltage fuses
• Low-voltage switchgear and control gear assemblies
• Low-voltage switchgear and control gear including dimensional standardization
• Luminaires and associated equipment
• Mains communicating systems
• Measuring equipment for electrical and electromagnetic quantities
• Measuring relays and protection equipment
• Miniature fuses
• Optical radiation safety and laser equipment
• Photo electronic controls for road lighting
• Power capacitors
• Power electronics
• Relays
• Rotating machinery
• Safety of electronic equipment within the fields of Audio/Video, Information Technology and Communication Technology
• Safety of household and similar electrical appliances
• Safety of machinery: electro technical aspects
• Safety of measuring, control, and laboratory equipment
• Small power transformers, reactors, supply units and similar products
• Solar photovoltaic energy systems
• Solar photovoltaic energy systems
• Switches for appliances
• Switches for household and similar fixed electrical installations
• Transmitting equipment for radio communication
• Wind turbine systems

• Acoustics
• Advanced Manufacturing Technologies
• Aircraft ground support equipment
• Atomizing oil burners and their components - Function - Safety – Testing
• Centrifuges - Safety requirements
• Chains, ropes, webbing, slings and accessories – Safety
• Compressors – Safety
• Conductor cars
• Construction equipment and building material machines – Safety
• Continuous handling equipment and systems – Safety
• Conveyor belts
• Cranes – Safety
• Doors, windows, shutters, building hardware and curtain walling
• Equipment for destruction of information carriers
• Equipments for making and shaping of metals - Safety requirements
• Ergonomics
• Eye protective equipment
• Fans – Safety
• Fire service equipment
• Food processing machinery - Safety and hygiene specifications
• Foundry machinery
• Hand-held, non-electric power tools – Safety
• Industrial thermoprocessing – Safety
• Industrial Trucks – Safety
• Internal combustion engines
• Lasers and laser-related equipment
• Leather and imitation leather goods and footwear manufacturing machinery
• Lifting platforms
• Light and lighting
• Low-voltage switchgear and controlgear including dimensional standardization
• Machine tools – Safety
• Machines for underground mines – Safety
• Mechanical vibration and shock
• Packaging machines – Safety
• Passenger, goods and service lifts
• Portable grinding machines - Mechanical safety
• Potentially explosive atmospheres - Explosion prevention and protection
• Power electronics
• Power-operated warehouse equipment
• Printing and paper machinery – Safety
• Pumps
• Railway applications
• Refrigerating systems, safety and environmental requirements
• Rubber and plastics machines – Safety
• Safety of hand-held and transportable motor-operated electric tools
• Safety of household and similar electrical appliances
• Safety of machinery
• Safety of machinery: electrotechnical aspects
• Sewing machines
• Shop fabricated metallic tanks & equipment for storage and for service stations
• Surface treatment equipment – Safety
• Tannery machinery – Safety
• Textile machinery and machinery for dry-cleaning and industrial laundry
• Tractors and machinery for agriculture and forestry
• Waste management - Containers and their technical equipment
• Wind turbine systems
• Woodworking machines – Safety

• Measuring instruments

• Active implantable medical devices – CEN’
• Biocompatibility of medical and dental materials and devices
• CEN/CENELEC coordination Working Group on quality supplements
• CEN/CENELEC Joint Working Group Active Implantable Medical Devices
• Clinical investigation of medical devices
• Criteria for conformity assessment bodies
• Electrical equipment in medical practice
• Medical alarms and signals
• Quality systems - Particular requirements for the EN ISO 9000 series – CEN
• Risk Analysis
• Sterilization of medical devices
• Sterilizers for medical purposes
• Symbols, information - nomenclature for regulatory data exchange

• Biocompatibility of medical and dental materials and devices
• CEN/CENELEC coordination Working Group on quality supplements
• Chemical disinfectants and antiseptics
• Clinical investigation of medical devices
• Criteria for conformity assessment bodies
• Dentistry
• Electrical equipment in medical practice
• Electro acoustics
• Hearing aids and audiometers
• Lasers and laser-related equipment
• Medical alarms and signals
• Medical devices utilizing tissues
• Non-active medical devices
• Non-active surgical implants
• Ophthalmic optics
• Optical radiation safety and laser equipment
• Quality systems - Particular requirements for the EN ISO 9000 series – CEN
• Rescue systems
• Respiratory and anaesthetic equipment
• Risk Analysis
• Sterilization of medical devices
• Sterilizers for medical purposes
• Symbols, information - nomenclature for regulatory data exchange
• Technical aids for disabled persons
• Transportable gas cylinders

• Automatic operating analytical appliances including In-Vitro-Diagnostic Medical Devices
• In vitro diagnostic medical devices
• Safety of measuring, control, and laboratory equipment
• Symbols, information - nomenclature for regulatory data exchange

• Acoustics
• Equipment and tools for live working
• Ergonomics
• Eye protective equipment
• Foot and leg protectors
• Head protection
• Hearing protectors
• Protection against falls from height including working belts
• Protective clothing including hand and arm protection and lifejackets
• Respiratory protective devices
• Sports, playground and other recreational equipment

• Aluminium and aluminium alloys
• Automatic controls for household use
• Copper and copper alloys
• Cryogenic vessels
• Flanges and their joints
• Flat products for cold working
• GRP tanks and vessels
• Industrial piping and pipelines
• Industrial valves
• Liquefied petroleum gas equipment and accessories
• Manual means of fire fighting equipment
• Non-destructive testing
• Plastics piping systems and ducting systems
• Refrigerating systems, safety and environmental requirements
• Safety of household and similar electrical appliances
• Shell and water tube boilers
• Shop fabricated metallic tanks & equipment for storage and for service stations
• Steel castings
• Steel forgings
• Steel tubes and fittings for steel tubes
• Steels for heat treatment, alloy steels and free-cutting steels
• Steels for pressure purposes – Qualities
• Structural steels - Grades and qualities
• Technical conditions of delivery and quality control
• Threaded and non-threaded mechanical fasteners and accessories
• Transportable gas cylinders
• Unfired pressure vessels
• Utensils in contact with food
• Welding
• Wire-rod - Qualities, dimensions, tolerances and specific tests

• BROADCASTING, TV, audio
• DECT Digital Enhanced Cordless Telecommunications
• DRRS Digital Radio Relay System
• EMC Electro-Magnetic Compatibility
• FWA Fixed Wireless Access (cf RLL, WLL, FRA)
• GMDSS Global Maritime Distress and Safety System
• GSM Global System for Mobile communications
• HIPERLAN HIgh Performance Radio Local Area Networks (LAN)
• IMT-2000 International Mobile Telecommunications 2000 (ITU project)
• PMR Private Mobile Radio
• RADIO
• SATELLITE (Cf terrestrial, aeronautical, maritime)
• SHORT RANGE (radio)
• TERMINAL (as opposed to NETWORK)
• TETRA Terrestrial Trunked Radio system

• Aluminium and aluminium alloys
• Non-destructive testing
• Threaded and non-threaded mechanical fasteners and accessories
• Unfired pressure vessels
• Welding