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Guideline I-05

Question

Answer

  1. The use of the harmonised standard is not mandatory.
  2. However, the directive did not include provisions to give presumption of conformity to documents other than harmonised standards.
    A manufacturer using another document shall describe in his technical documentation the solutions adopted to meet the essential requirements of the directive.
    The notified body (or the user inspectorate) shall validate, if required by the module chosen, these solutions.
  3. The technical requirements of the Directive are given in Annex I. When using a national standard, a professional code or a private technical document for fulfilling Annex I, only the technical content of this document is relevant. Further provisions of this document (e.g. about bodies or certification procedures) are not relevant for the application of PED.

Note:
See also PED Guideline I-06.