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 price 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 Communautaire European. 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 New Approach directives for CE Marking
- Directive Subject (short title of directive)
- 2006/95/EEC Low Voltage Equipment (LVD)
- 87/404/EEC Simple Pressure Vessels
- 88/378/EEC Toys Safety
- 89/106/EEC Construction Products
- 89/336/EEC Electromagnetic Compatibility (EMC)
- 89/686/EEC Personal Protective Equipment (PPE)
- 90/384/EEC Non-Automatic Weighing Instruments
- 90/385/EEC Medical Devices - Active Implantable
- 90/396/EEC Appliances Burning Gaseous Fuels
- 92/42/EEC New Hot-Water Boilers fired with Liquid or Gaseous Fuels (Efficiency Requirements)
- 93/42/EEC Medical Devices - General (MDD)
- 94/62/EC Packaging and Packaging Waste
- 95/16/EC Lifts
- 97/23/EC Pressure Equipment (PED)
- 98/37/EC Machinery Safety
- 98/79/EC Medical Devices - In Vitro Diagnostic (IVD)
- 99/5/EC Radio Equipment and Telecommunications Terminal Equipment
- 00/9/EC Cableway Installations designed to Carry Persons
- 04/22/EC Measuring Instruments