Obligations of the manufacturer

This article explains what the obligations of the manufacturer under the GPSR are.

The GPSR requires a manufacturer to:

  • Ensure Compliance: Before placing a product on the market, the manufacturer must ensure the product meets the general safety requirement outlined in the Regulation.
  • Conduct a Risk Assessment : The GPSR requires the manufacturer conducts an internal risk assessment for the product before placing it on the market, and to take the necessary safety measures to mitigate the risks.
  • Compile Technical Documentation: The manufacturer must prepare technical documentation to show the product complies with the general safety requirement. The technical documentation should include a general description of the product and its key characteristics relevant to safety assessment.
  • Provide Means for Product Identification: The manufacturer must ensure the product is easily identifiable by including a batch or serial number or another identifying element. Only if the product's size or nature makes this impractical, provide the information on the packaging or accompanying documentation.
  • Provide Contact Information: The manufacturer must indicate its name, registered trade name or trademark, postal address, electronic address, and, if applicable, the contact details of a single point of contact for consumers.
  • Provide Instructions and Safety Information: Where necessary, the manufacturer must accompany the product with clear instructions and safety information. If instructions or safety information are provided, it must be in a language easily understood by consumers.
  • Respond to Safety Issues: If a manufacturer identifies that a product placed on the market is dangerous, they must:
    • Take corrective measures to ensure conformity, such as withdrawing or recalling the product if appropriate.
    • Inform affected consumers of the corrective actions.
    • Notify the relevant Market Surveillance Authorities (MSAs) via the Safety Business Gateway.
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Last updated on December 15, 2024