CE Marking - The "New Approach" Directives

Under the EU’s New Approach Directives legislative, harmonization for product conformity is met through essential protection requirements and only products fulfilling these essential protection requirements can be placed on the market, or brought into service.  Manufacturers may chose between different conformity procedures as given in each directive.  These include  the application of harmonised standards, but the manufacturer may choose other methods that provide compliance with the essential protection requirements.   Standards only give a presumption of conformity, and the applicable harmonized standards are to be found in the Official Journal of the EU.
 Essential requirements set up by New Approach Directives may overlap or complement each other, depending on the hazards covered by these requirements that are related to the product in question.  The placing on the market, or bringing into service, can only take place when the product complies with the provisions of the applicable directives and when the conformity assessment has been carried out in accordance with all applicable directives.  Where the same product or hazard is covered by two or more directives, the application of other directives can sometimes be excluded following an approach that includes a risk analysis of the product, with a view to the intended use as defined by the manufacturer.
 Essential protection requirements lay down the necessary elements for protecting the public interest.  These are mandatory and only products meeting them may be placed on the market.  They are applied as a function of the hazards inherent to a given product.
The directives requiring CE marking affect the following product groups:
  • Active implantable medical devices (excludes surgical instruments)
  • Appliances burning gaseous fuels
  • Cableway installations designed to carry persons
  • Construction products 
  • Eco-design of energy related products
  • Electromagnetic compatibility
  • Equipment and protective systems intended for use in potentially explosive atmospheres
  • Explosives for civil uses
  • Hot-water boilers
  • In vitro diagnostic medical devices
  • Lifts
  • Low voltage
  • Machinery
  • Measuring Instruments
  • Medical devices
  • Noise emission in the environment
  • Non-automatic weighing instruments
  • Personal protective equipment
  • Pressure equipment
  • Pyrotechnics
  • Radio Equipment
  • Recreational craft
  • Restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS 2
  • Safety of toys
  • Simple pressure vessels

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