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GPSR

Pila di file

EU Conformity: Technical File, Risk Analysis and Management on the Safety Gate

Applicable from 13 December 2024, Regulation (EU) 2023/988 (GPSR), on general product safety , is also called the General Product Safety Regulation, and applies to all products (with the exception of food, pharmaceuticals and medical devices) unless there are specific product safety standards.


Among the innovations introduced by the new regulation compared to the General Product Safety Directive 2001/95/EC: the obligation to evaluate the safety of the product which must consider, for example: the design, the technical characteristics, the composition of the product as well as the category of consumers to which it is aimed, the type of packaging.

 

It will be necessary to create a technical documentation (technical file), accompanied by a risk analysis and corrective measures that establishes the specific product safety requirements for online markets in order to protect consumers from dangerous products. The product is considered safe when it does not present any risk or only minimal risks compatible with the use of the product, considered acceptable and consistent with a high level of protection of the health and safety of consumers (introduction of a market surveillance system through the rapid alert system Safety gate and Safety business gateway).


We can help you draft the technical file, carefully analyzing the product typology so that it complies with the general safety obligation and registering at the Safety Gate and Safety Business Gateway.

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