CE Marking

CE Mark

The initials “CE” stand for Conformity Europeans, which is French for “European Conformity”. The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive.

Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries.

For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that.

Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as a means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment.

The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive; refers to Communauté Européen. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.

The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.

How Do You Acquire CE Marking

There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.

  • Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
  • Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
  • Choose the conformity assessment procedure from the options called out by the directive for your product. 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. 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. Options for products with greater risks can require tests, audits or additional certificates from a notified body.
  • Select the applicable product standards and test methods for your product and select an independent lab If the product testing is to be done externally.
  • Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate in Europe a representative to produce technical documentation in a timely fashion when called upon to do so. The directives require for many products that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
  • Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer’s name, address and signature. The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.
  • ffix the CE Marking to your product. There are specific rules to adhere to in 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

List of Products need CE Marking:-

ISO 9001:2000 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:

  1. Appliances Burning Gaseous Fuels (AppliGas)
  2. Cableway Installations to Carry Persons
  3. Low Voltage Electrical Equipments.
  4. Construction Products
  5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
  6. Explosives for Civil Uses
  7. Hot Water Boilers
  8. Lift
  9. Machinery
  10. Measuring Instruments
  11. Medical Devices
  12. Active Implantable Medical Devices
  13. In Vitro Diagnostic Medical Devices
  14. Non-automatic Weighing Instruments
  15. Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
  16. Personal Protective Equipment (PPE)
  17. Simple Pressure Vessels
  18. Pressure Equipment
  19. Recreational Craft
  20. Toys

List of New Approach directives for CE Marking
Subject (short title of directive)

    1. Low Voltage Equipment (LVD)
    2. Simple Pressure Vessels
    3. Toys Safety
    4. Construction Products
    5. Electromagnetic Compatibility (EMC)
    6. Personal Protective Equipment (PPE)
    7. Non-Automatic Weighing Instruments
    8. Medical Devices – Active Implantable
    9. Appliances Burning Gaseous Fuels
    10. New Hot-Water Boilers fired with Liquid or Gaseous Fuels (Efficiency Requirements)
    11. Explosives for Civil Uses
    12. Medical Devices – General (MDD)
    13. Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX)
    14. Recreational Craft
    15. Packaging and Packaging Waste
    16. Lifts
    17. Pressure Equipment (PED)
    18. Machinery Safety
    19. Medical Devices – In Vitro Diagnostic (IVD)
    20. Radio Equipment and Telecommunications Terminal Equipment
    21. Cableway Installations designed to Carry Persons
    22. Measuring Instruments

Here at Focusiso Management Certification Pvt LTd. we offer a full range of Self Certification for CE Mark compliance and CE management services, for any industry, across the globe. Expert CE Mark Advisers can guide you through the CE compliance maze, assisting you to correctly CE Label your Machinery give us a call to see how we can help you.

CE Compliance

Delivering safety approvals, CE Mark Compliance, CE Consultancy and Self CE Certification solutions to industry and commerce. Applying the appropriate CE Standards such as EN 12100, EN 60204 and EN 14121 to successfully deploy CE Marking, European Machine Safety Regulations, Machine Guarding advice, risk assessment, hazard analysis and Technical Files, under any type of European CE approvals and CE compliance management systems.

Client Base

We help many machine manufacturers, distributors and importers of all types of machinery from around the world to CE Mark their machines, products, processes and systems to ensure CE Compliance to the Essential Health & Safety Requirements of the Machinery Directive, Low Voltage Directive, EMC Directive, Pressure Equipment Directive and ATEX Directive and many more areas of European Safety Legislation

European Machine Safety Regulations

The European Machine Safety Regulations make it an offence to supply machinery or safety component UNLESS IT IS SAFE. At CE Mark Consultancy we can undertake the work to create your Technical Files, or assist you, to sell your product in compliance with the appropriate European Machine Safety legislation.

CE Mark Advisory Service

Here at CE Mark Consultancy we provide a full advisory service and applying our CE Mark Scheme for CE Marking, CE Mark Certification, Machinery, Low Voltage, EMC and Pressure Equipment Directives. Our advisory service provides for free impartial advice and we can guide you through all aspects of CE Compliance If you have any questions relating to CE Marking, Quality, Environmental or Occupational Health & Safety Systems then give us a call and we will be glad to advise you.

CE Mark Advisors

We have a dedicated team of advisors with a wealth of experience spanning all industry sectors, having considerable knowledge of all aspects of CE Marking, Machine Safety, Risk and Hazard Analysis. Our engineering expertise covers every aspect of safety for all types of machinery.

Industry Sectors

Typical industry sectors include agriculture, automotive, building trades, ceramics, bottling plants, compression presses (1000 tonne), effluent control, electrical consumer products, food cooking, processing and testing, forestry, ground care (mowing machines), horticultural, machine tools, mechanical handling, medical, packaging, plastic moulding, pressure vessels, testing machinery, printing, specialised press tools, spraying equipment, snow clearing equipment, waste disposal and many more.


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