(P) Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products

Every Personal Protective 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 before categorizing your product for submission to the Notified Body so that they may guide you through the Manufacturer Responsibilities.

Appoint Obelis European Authorized Representative Center as your “European Authorized Representative” within the EU. (PPE 89/686/EEC art.8,1)

  • 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, National or International.
  • Obelis European Authorized Representative assists in assessing your product category according to the guidelines laid out in the PPE directive. Articles 2, 3 & 4 of the 89/686/EEC describe the product categories.
  • Obelis European Authorized Representative can direct you to identify an appropriate approved inspection body according to your product categorization. Notified Bodies List.
  • Obelis European Authorized Representative will assist you to prepare a “Technical File” , and Quality Manual, as outlined in the Directive (PPE Annex II 1.4).
  • Obelis European Authorized Representative will guide you in how to implement and operate a “Quality Assurance System” as required in Article 11, 1.
  • Obelis European Authorized Representative reviews and assures you have all the necessary information on your product labeling (PPE Annex II 1.4).
  • Obelis European Authorized Representative will assist you with your obligation to 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.)

Contact us for our services, your questions, and our assistance.

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