3)

Report accidents related to the safety of products When you are informed or obtain knowledge about an accident caused by a product you placed or made available on the market, you must notify the accident to the competent authorities of the Member State where the accident has occurred, as soon as possible via the Safety Business Gateway. When you are informed by importers or distributors that such accidents have occurred, you must notify these accidents to the competent authorities yourself or instruct the importer, or one of the distributors, to make the notification. What constitutes an accident related to the safety of products? Accidents that must be notified are occurrences associated with the use of a product that resulted in an individual’s death or in serious adverse effects on that individual’s health and safety. These effects can be permanent or temporary. They can include injuries, other damage to the body, illnesses and chronic health effects. Which tool do I have to use to notify the accident? You must use the Safety Business Gateway (see point 3.4.3). What type of information do I have to include in the notification? You must specify: the type and identification number of the product; and the circumstances of the accident, if known (for instance, the age of the victim of the accident if relevant, as well as how the product was being used when the accident happened).

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.