Drugdu.com expert's response:

The Relationship Between EU GPSR Compliance and CE Certification

Mandatory Compliance with GPSR: GPSR (General Product Safety Regulation) is a regulation of the European Union aimed at ensuring that products sold on the market are safe and do not pose a harm to consumers. Compliance with GPSR regulations is mandatory for most products.

Definition and Scope of CE Certification: CE certification is a product compliance mark indicating that a product meets the safety, health, and environmental protection requirements of the European Union. It primarily applies to certain specific categories of products, such as electronics and machinery.

Relationship Between GPSR and CE Certification: GPSR compliance and CE certification are two different compliance systems, but they overlap in some aspects. The directives and standards upon which CE certification is based correspond to the safety requirements of GPSR, but their focuses and scopes of application differ.

Not all products that need to comply with GPSR regulations require CE certification. Some products (such as simple consumer goods that are non-electrical and non-mechanical) may not need CE certification but must still meet the general safety requirements of GPSR.

Conditions for EU GPSR Compliance

Product Safety: Products must be hazard-free and, when used in the normal manner, must not pose a risk to the health and safety of consumers.

Risk Assessment and Management: Manufacturers must assess the potential risks that their products may pose to consumers, including both normal and accidental use scenarios, and take appropriate measures to eliminate or reduce these risks.

Appropriate Design and Manufacturing: Products should be designed and manufactured in a reasonable way to minimize any potential safety hazards.

Product Instructions and Labels: Products should provide clear and accurate labels and instructions to ensure that consumers can understand how to use the product and be aware of any potential risks. If a product has potential risks, manufacturers should indicate warning information on the product.

Product Traceability and Recall: Manufacturers and importers need to keep sales records to trace the origin and sales path of the product in case of safety issues. If a product is found to have safety risks, manufacturers must have a recall mechanism and ensure that problematic products can be quickly and effectively removed from the market.

Appointment of an EU Responsible Person: From December 13, 2024, all products sold in the European Union and Northern Ireland (including both CE and non-CE products) must have an EU responsible person appointed. This person can be the manufacturer (registered in the EU), importer (registered in the EU), authorized representative (a company registered in the EU designated as the responsible person in writing by the manufacturer or brand), or a delivery service provider registered in the EU responsible for delivering the goods.

In summary, EU GPSR compliance does not entirely depend on CE certification. Whether a product requires CE certification depends on whether it belongs to the specific category that requires CE certification. However, regardless of whether a product needs CE certification, it must meet the general safety requirements of GPSR. Therefore, manufacturers should carefully assess the safety risks of their products before placing them on the EU market and ensure that they comply with GPSR and any applicable CE certification requirements.