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New and Global Approach Directives


European Product Directives are currently prepared by the Commission incorporating the "New Approach and the Global Approach" philosophy.

The "New Approach" Directives establish a uniform marking system known as the CE Marking. Directives written prior to the New and Global Approach do not take CE Marking into account and are known as "Old Approach" Directives.

"Old Approach" Directives tended to include precise technical details within the text of the legislative document. This made assessment against the legislation relatively easy, however the Directives necessitated continuous adaptations to technical progress. A new material or novel product, that was not foreseen at the time of writing the legislation, might not fit the technical requirements and would make it illegal, even if the product is perfectly safe.

To avoid this situation, the New Approach Directives now only set out Essential Safety Requirements in general terms. They do not contain information on how the essential requirements could or should be met. Harmonised standards provide the manufacturer with one solution for satisfying the essential requirements of the Directive. A manufacturer is not obliged to apply a harmonised standard. A solution, alternative to harmonised standards can be used provided that the manufacturer demonstrates equivalent safety.


The purpose of the "New Approach" is to establish one set of regulations for all to follow to ensure the free movement of goods throughout the EEA. This necessitates the consistent application of these rules throughout the Community. When the regulations are applied properly, manufacturers may then affix the CE marking to their products, which allows the products to be placed on the EEA market.

Another new strategy called the "Global Approach" supplements the New Approach. The Global Approach establishes conditions for reliable conformity assessment. Conformity assessment procedures are subdivided into a number of modules. There are eight standard modules but these can be slightly altered in some Directives.


The eight conformity assessment modules are:

  • Module A - Internal Production Control
  • Module B - EC Type Examination
  • Module C - Conformity to Type
  • Module D - Production Quality Assurance
  • Module E - Quality Assurance for Final Testing
  • Module F - Product Verification
  • Module G - Unit Verification
  • Module H - Full Quality Assurance


It is normal for Modules A, G or H to be applied individually and for Module B to be applied in conjunction with one of Modules C, D, E or F.
Further details on the New and Global Approach are given in the "Guide to the implementation of directives based on the New Approach and the Global Approach".

   
   
 
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