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CE Marking

EU Directives and CE marking of products and machinery for export into the European Union is a specialized area for most manufacturers, involving a combination of EMC test, Electrical safety test, Machinery Safety assessment, ATEX and perhaps pressure systems assessment. To ensure your product meets all applicable directives requires a significant amount of documentation to accompany any test reports. The test and documentation burden may place significant demands on your staff and resources. EU Compliance Services turn key approach manages all of the compliance issues allowing you and your staff, leaving you to concentrate on doing what you do best – designing and manufacturing your products.

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EU Compliance Services provides turnkey solutions for its clients, taking responsibility for the complete certification process from test planning to final preparation of your declaration of conformity.

EMC Directive 2004/108/EEC
LVD Directive (Electrical Safety) 2006/95/EEC
Machinery Safety Directive 2006/42/EC
Pressure Equipment Directive 97/23/EEC
ATEX 94/9/EC

Free movement of goods and products is a cornerstone of the single European market. The mechanisms in place to achieve this aim are based upon mutual recognition and technical harmonization. A new regulatory technique and strategy was laid down by the EU parliament which resulted in the “New Approach” to technical harmonization and standardization. The following principles were established:
    Legislative harmonization was limited to essential requirements.
    Technical specifications which give a presumption of conformity to essential requirements will be laid down in harmonized standards.
    Application of harmonized standards remains voluntary as one of the available routes to compliance.
    Products in compliance with harmonized standards benefit from a presumption of conformance with essential requirements.
The resulting legislation allowed for “New Approach Directives” to be developed and published within the EU Community for a number of different areas addressing various phenomena. The objective is to provide flexibility of conformity assessment over the entire design and manufacturing process in order to be adapted to the needs of individual organizations.

Products in compliance with all provisions of ALL applicable directives (New Approach) can affix the “CE Mark” to indicate that the product has been subject to the appropriate conformity assessment procedures of the applicable directives.
A EU Declaration of Conformity must be drawn up before the CE mark is affixed to the product.

The CE marking is mandatory and must be affixed before the product is placed on the EU market.  Where products are subject to several directives, conformity must be to the provisions of all these directives.

CE marking must be affixed by the manufacturer or by his authorized representative.  CE mark must be affixed to the product, its data plate or if this is not possible , it must be affixed to the packaging and accompanying documents.
CE mark must be affixed visibly, legibly and indelibly.  CE mark must be at least 5 mm in height and take the form described in EU legislation.

Complete list of new approach directives subject to CE marking;
    90/396/EEC Appliances burning gaseous fuels
    2000/9/EC Cableway installations designed to carry persons
    89/106/EEC Construction products
    2004/108/EC Electromagnetic compatibility
    94/9/EC Equipment and protective systems in potentially explosive atmospheres
    93/15/EEC Explosives for civil uses
    95/16/EC Lifts
    2006/95/EC Low voltage equipment
    2006/42/EC Machinery safety
    2004/22/EC Measuring instruments
    90/385/EEC Medical devices: Active implantable
    93/42/EEC Medical devices: General
    98/79/EC Medical devices: In vitro diagnostic
    92/42/EEC New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements)
    90/384/EEC Non-automatic weighing instruments
    94/62/EC Packaging and packaging waste
    89/686/EEC Personal protective equipment
    97/23/EC Pressure equipment
    1999/5/EC Radio and telecommunications terminal equipment
    94/25/EC Recreational craft
    87/404/EEC Simple pressure vessels
    88/378/EEC Toys safety


More information can be obtained from www.newapproach.org.

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    Regulatory Consultancy
    Test Planning
    Project Management
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