In 1985, the European Community adopted a "New Approach to Technical Harmonization and Standards". To promote free movement of goods within Europe, they agreed to gradually remove the product safety requirements of each individual country and replace them with same essential requirements to cover all of Europe. These essential requirements are contained in new approach EC product directives and detailed in harmonized European (EN) standards.

When products meet the essential requirements of the directive or EN standard the manufacturer puts the appropriate CE mark on the product. National government then cannot stop the sale of CE marked products for safety reasons. CE marking is mandatory for products being sold in Europe and it is a criminal offence to offer for sale products not meeting the essential requirements.

GOAL & PURPOSE

The CE mark on a product is an assurance that the product is safe, bearing in mind that the product should be used as intended.

The CE mark should be affixed to the product, to its instruction manual or to packaging in a visible, easily legible and indelible form. The mark must appear on the product unless there are good technical reasons why it cannot appear and it must be at least 5mm high.

The letters, "CE", indicate that the manufacturer has undertaken all assessment procedures required for the product. The CE mark is not a quality mark and does not indicate conformity to a standard; rather, it indicates conformity to the legal requirements of the EU Directives. The products requiring CE mark are:

• Medical Device Directive (93/42/EEC)
• Electromagnetic Compatibility (89/336/EEC)
• Gas Appliances/Hot Water Boilers (90/396/EEC)
• Low Voltage (73/23/EEC)
• Machinery (89/392/EEC)
• Non-Automatic Weighing Equipment (90/384/EEC)
• Personal Protective Equipment (89/686/EEC)
• Pressure Equipment (97/23/EC)
• Simple Pressure Vessels (87/404/EEC)
• Toy Safety (88/378/EEC)
• Radio and Telecommunication Terminal Equipment (1999/5/EC)
• Construction Products (CPD) (89/106/EEC)
• Active Implantable Medical Devices (AIMD) (90/385/EEC)
• Explosives for Civil uses (93/15/EEC)
• Medical Devices (MDD) (93/42/EEC)
• Satellite Earth Station Equipment (93/97/EEC REPEALED BY 98/13/EC)
• Equipment in Potentially Explosive Atmospheres -"ATEX" (94/9/EC)
• Recreational Craft (94/25/EC)
• Packaging and Packaging Waste (94/62/EC)
• Lifts (95/16/EC)
• Energy Efficiency: Household Refrigerators & Freezers (96/57/EC)
• In Vitro Diagnostic Medical Devices (98/79/EC)
• Cableway Installations for Passengers (2000/9/EC)
• Noise Emission in the environment by equipment for use outdoors (2000/14/EC).