Compliance with the General Product Safety Directive

Compliance with the General Product Safety Directive

Manufacturers need to determine the applicable standards for the product, at European, and/or international and/or national level, and then identify the appropriate conformity assessment module according to the product characteristics. The technical documentation to be compiled per product type should include the following:

  • Safety Evaluation and Risk Assessment Report,
  • Complete (exhaustive) list of standards your product is currently complying with (EN, international or nationals),
  • Declaration of Conformity of the product,
  • Quality Management System in place or ISO Certificate,
  • Instructions of Use including any relevant warning concerning the correct use of the product and explanation of any possible risks your product expose the end user to,
  • Labeling: labels should clearly mention both manufacturer's name and complete details (address, tel., fax, email address) and the "European Authorized Representative" complete details (name, address, email address),
  • Vigilance & Traceability activities such as tracking any compliants reported by the users.

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