Product approval process for CE Marking for EMC Directive


New EMC Directive 2004/108 / EC has now replaced the previous EMC Directive 89/336 / EC of the end of 2-year transition period. The new directive makes some changes, including having all products have the technical documentation, and remove the requirement to have this reviewed by the competent body if harmonized standards are not applied in full.

Annex II of [4] says

  1. manufacturer shall perform electromagnetic compatibility assessment of apparatus, based on relevant phenomena, in order to meet the protection requirements set out in Annex I, paragraph 1 of the correct application of any relevant harmonized standards whose references have been published in the Official Journal European Union shall be equivalent to the implementation of the electromagnetic compatibility assessment.
  2. Electromagnetic compatibility assessment shall take into account all normal intended operating conditions. If the equipment is capable of taking different configurations, the electromagnetic compatibility assessment should confirm whether the apparatus meets the protection requirements set out in Annex I, point 1 in all possible configurations identified by the manufacturer as representative of the proposed use.

IV Annex [4] says

  • The technical documentation must enable conformity of the equipment with the essential requirements to be assessed. It will take the design and manufacture of equipment, in particular:
  • General description of the equipment;
  • Evidence of compliance with the harmonized standards, if any, apply to all or part of
  • If the manufacturer has not applied harmonized standards, or has applied them only in part, the description and explanation of the measures to fulfill the essential requirements, including a description of the electromagnetic compatibility assessment set out in Annex II, Section 1, results of calculations of design, examinations, test reports, etc.

The simplest way to demonstrate the “Apply” relevant harmonized standards. “Enable” is not defined in the Directive or in guidance, but is generally accepted that means that the product would meet the standards if tested against them

  • The new products this is the easiest to reach by performing tests and record the results of
  • For changing products or varieties of previously tested products, a combination of technical arguments with some more testing is usually enough.


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