GPSR focus: risk analysis and technical documentation template

Under the General Product Safety Regulation (GPSR), all manufacturers must ensure that a product is safe when placing it on the Union market. This applies to all products, whether sold through traditional channel or through means of distance sales. The GPSR defines manufacturers as any natural or legal person who manufacturers products or has them designed or manufactured and markets them under their name or trademark. Notably, businesses of all sizes are concerned by the new GPSR obligations. As part of their obligations (Article 9 of the GPSR), manufacturers must for all products:

  • Conduct an internal risk analysis for all the products
  • Compile a technical documentation

Internal risk analysis for GPSR products

The technical documentation should be based on an internal risk assessment conducted by the manufacturer. When conducting a risk analysis, some of the product aspects to take into account are general characteristics, appearance, presentation, category of consumers, effects on other products, cybersecurity features, evolving functionalities, among others.

Technical documentation under GPSR: template for all products

The purpose of technical documentation is to provide information on the product demonstrating that the product is safe and compliant with the applicable requirements.

While the exact content will vary product-by-product, all products must have a technical documentation.

The European Commission recently provided a draft template which manufacturers can use as guidance to start compiling their GPSR technical documentation.

Source: (European Commission, 2024)

Responsible person and GPSR compliance

GPSR products must have a EU-based responsible person. Do you want more information on GPSR compliance in the European Union? Write an email to prodlaw@obelis.net or contact us here.

References:

European Commission (2024). EU General Product Safety Regulation GPSR – Regulation (EU) 2023/988 on general product safety. Retrieved on 24/12/2024.

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