Division 5.1 Background to notifications (obligation of post-marketing monitoring)

In addition to the duty to comply with the general safety requirement for their products, producers and distributors have the obligation, as professionals and within the limits of their activities, to ensure an adequate follow-up of the safety of products they supply. The obligations for producers and distributors established by GPSD in that respect, such as information to consumers, post-marketing monitoring of product risks, withdrawing dangerous products, etc., have been mentioned above. The obligations on producers apply to manufacturers, but also to any other members of the supply chain who can affect the safety characteristics of a product.

Various types of evidence may become available to operators within the framework of their post-marketing responsibilities which may lead to a notification, such as and among others:

• reports or other information on accidents involving the company's products;

• safety-related complaints received from consumers, directly or through distributors or consumer associations;

• insurance claims or legal actions concerning dangerous products;

• safety-related non-compliance reported via the company's quality control procedures;

• any information relevant for identifying non-compliances with safety requirements that is brought to the company's attention by other organisations such as market surveillance authorities, consumer organisations or other companies;

• information on relevant scientific developments on product safety.