Certificate of Conformity (COC)

CE Marking and Self-Declaration

In order to CE mark a product, the manufacturer or their representative in Europe has to make a self-declaration describing that the product is in conformity with the relevant Directives.

New General Product Safety Regulation (GPSR)

The European Commission introduced a new General Product Safety Regulation (GPSR) December 13, 2024. This regulation will affect the conditions for CE marking and the requirements for sales in Europe.

Key impacts for a manufacturer 

Enhanced Safety Requirements

Manufacturers must ensure that all products placed on the market are safe. This includes conducting thorough risk assessments and maintaining detailed technical documentation.

Product Traceability

There are stricter requirements for product traceability. Manufacturers need to ensure that products can be traced throughout the supply chain, which helps in quickly addressing safety issues.

Obligations for Online Sales

The GPSR includes specific provisions for online sales. Manufacturers must have a responsible economic operator established within the EU to handle compliance and safety issues.

Accident Reporting

Manufacturers are required to report accidents involving their products to the relevant authorities. This helps in monitoring and improving product safety.

Market Surveillance

There will be reinforced market surveillance rules. Authorities will have more power to monitor and enforce compliance, ensuring that unsafe products are quickly removed from the market.

Recall Procedures

The regulation introduces specific rules for product recalls, including a mandatory recall notice template and the right to remedy for consumers. This ensures that recalls are handled efficiently and effectively.

New Technologies

The GPSR addresses challenges posed by new technologies, ensuring that products incorporating these technologies meet safety standards.