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Steps to obtain CE Marking for your Machinery Directive 98/37/EC Product

Each Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis European Authorized Representative for steps tailored to your company. It is important to select your European Authorized Representative before choosing a Notified Body; Particularly in assisting you with the Manufacturer Responsibilities before submission to the Notified Body.

Appoint Obelis European Authorized Representative Center (O.E.A.R.C.) as your “European Authorized Representative” within the EU.

  • Obelis European Authorized Representative will assist you to identify all applicable EU Directives (laws) for your product.
  • Obelis European Authorized Representative will guide you in determining the applicable Standards: European, International or National.
  • Obelis European Authorized Representative assists in assessing your product according to the “essential requirements” in the Directives. Article 8 of the MD describes the conformity assessment routes, and detailed information on the assessment “modules” is given in Annex I of the MD.
  • Obelis European Authorized Representative can direct you to identify the appropriate conformity assessment module according to your product classification.
  • Obelis European Authorized Representative will assist you in preparing a “Technical File” including a user manual, as outlined in the Directive (MD Annex VI 2.).
  • Obelis European Authorized Representative will assist you, if required, with selecting a “Notified Body” within the EU Territory, to perform the official conformity assessment tasks.
  • You assemble the required approvals and certificates and prepare a “EC Declaration of Conformity” per product according to the applicable Directives.

(Note that the Declarations of Conformity and Technical Files can be written in English.)

Last updated Apr 22, 2009

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