CE Marking Directive 93/68/EEC of July 22, 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).
CE Marking 93/68/EEC
The CE Marking Directive 93/68/EEC was adopted on July 22, 1993 and its purpose being to introduce a harmonized set of rules relating to the affixing and use of CE marking.
The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”.
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 legislations in practice by many of the so-called product directives.
It proves to the buyer or user that this product fulfills all essential safety and environmental requirements as they are defined in the so-called European Directives.
The CE Marking Directive gives a detailed description of the initials CE and any other marks specific to a particular directive and the ways conformity may be acquired.
Products meeting the requirements of all appropriate directives must carry the CE mark. It may not be smaller than 5mm in its vertical height and the proportions should be maintained whatever its size. The grid does not form part of the marking. It is for information only. It should be noted that the C and the E are not formed by perfect semicircles.
The manufacturer needs to:
- Be European
- Have an official department in the European Community
- Have an official agent or representative that is willing to share the liability for the CE marking and hold the Declaration of Conformity.
The CE Marking of products is intended to support the free movement of goods within the European Economic Area. All products that bear CE marking must comply with all provisions of the applicable directives. Where a product carries appropriate CE marking, the member countries of the European Economic Area must allow the product to be placed on the market.
CE Marking directives cover many product areas. The current CE marking directives are:
- Low Voltage Directive 73/23/EEC (amended 93/68/EEC)
- Simple Pressure Vessels 87/404/EEC (amended 90/488/EEC, 93/68/EEC)
- Toy Safety 88/378/EEC (amended 93/68/EEC)
- Construction Products 89/106/EEC (amended 93/68/EEC)
- Electromagnetic Compatibility 89/336/EEC (amended 92/31/EEC, 93/68/EEC, 98/13/EC)
- Machinery 98/37/EC (amended 98/79/EC)
- Personal Protective Equipment 89/686/EEC (amended 93/68/EEC, 93/95/EEC, 96/58/EC)
- Non-Automatic Weighing Instruments 90/384/EEC (amended 93/68/EEC)
- Active Implantable Medical Devices 90/385/EEC (amended 93/68/EEC, 93/42/EEC, 98/79/EC)
- Gas Appliances 90/396/EEC (amended 93/68/EEC)
- Hot Water Boilers 92/42/EEC (amended 93/68/EEC)
- Civil Explosives 93/15/EEC
- Medical Devices 93/42/EEC (amended 93/68/EEC, 98/79/EC)
- Potentially Explosive Atmospheres 94/9/EC
- Recreational Craft 94/25/EC
- Lifts 95/16/EC
- Refrigeration Appliances 96/57/EC
- Pressure Equipment 97/23/EC
- Telecommunications Terminal Equipment 98/13/EC
- In-Vitro Diagnostics 98/79/EC
- Radio and Telecommunications Terminal Equipment 99/5/EC
New Approach Directives that do not require CE Marking are:
- Packaging and Packaging Waste 94/62/EC
- High Speed Rail Systems 96/48/EC
- Marine Equipment 96/98/EC
The Marking should be affixed to one of the following:
- the product itself
- the packaging of the product
- the instructions for use
- the guarantee certificate
By affixing the CE marking to the product a manufacturer is making a statement that product meets the requirement of all relevant directives. It is for the manufacturer to decide which directives are applicable.
The Manufacturer or Supplier should demonstrate that the product complies with the essential requirements, using one of the product conformity assessment modules available within the directive. One of the options is usually the assessment of the product by applying the relevant standards to the product, and/or the preparation of appropriate documentation such as the Technical File. The CE Mark should be affixed legibly and indelibly to the product. The manufacturer should prepare and sign a “Declaration of Conformity”.
Many of the CE Marking directives include provision for the appointment of Notified Bodies. These are organizations appointed by Member States in which they are based and whose details are “Notified” to the European Commission. The Commission must then publish these details in the Official Journal of the European Communities.
Notified Bodies perform specific functions, as defined by the directives, in relation to the assessment of compliance of specific products. For many of the directives their involvement is only mandatory for higher risk and safety critical products.
The label (inner & outer packaging) and manual of any device aimed to be made available within the EU Market should follow the language requirements which are exerted by the National Laws of each EU member states. The outcome of a correct compliance strategy would require the description of the device and its operating instructions along with precautions and warnings to be translated to the official language(s) of the EU state it is to be sold in.
The final artwork of a device labeling & instructions for use, must follow certain language requirements – click here to review the EU language requirements.