C)

Keep the manufacturer informed of any accident caused by a product and ensure that competent authorities are notified If you have knowledge of an accident caused by a product that you made available on the market, you should inform the manufacturer of this without undue delay. The manufacturer may instruct you to notify the competent authorities. If you have knowledge of an accident and the manufacturer of the product is not established in the EU, you should inform the responsible person of the product in the EU. This responsible person must ensure that the accident is notified to the competent authorities of the Member State where the accident has occurred. What constitutes an accident related to the safety of products? Accidents that must be notified refer to 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, and 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. Check list for the importer Before placing the product on the market: ✓ Ensure the product is safe. ✓ Ensure the manufacturer did the risk assessment and drew up the technical documentation. Keep this technical documentation for 10 years and provide it to authorities upon request. ✓ Ensure that the product identification details, the manufacturer’s identification and contact details, are correctly affixed to the product or its packaging, and that the product is accompanied by instructions and safety information if needed. ✓ Add your identification and contact details on/with the product. Ensure that this information does not obscure any other mandatory information. ✓ Ensure that there is a responsible person for the product in the EU and that its contact details and other required information are indicated on the product or on its packaging, the parcel or an accompanying document. It can be you! ✓ Set up internal processes for product safety. ✓ Ensure that storage or transport do not affect product safety or its labelling. ✓ Don’t place a non-conform or dangerous product on the market! In case of any non-conformity inform the manufacturer and the market surveillance authorities. After placing of the product on the market: ✓ If product safety issue arises: — Inform the manufacturer — Ensure that the manufacturer has taken corrective measures (for recalls it used the template recall notice and provided remedies). If not, you must immediately take them. — Ensure that the manufacturer informed consumers about dangerous products. If not, you must do so. — Inform national authorities via the Safety Business Gateway. ✓ Ensure that the manufacturer has a direct channel for consumer complaints about product safety. If not, you must provide it. Think about accessible formats. ✓ Investigate any complaints and keep other actors in the supply chain informed. ✓ Keep internal register of consumer complaints, product recalls and corrective measures taken. ✓ Report product-related accidents you become aware of, to the manufacturer and to the responsible person for the product in the EU. The manufacturer can instruct you to notify it to authorities via the Safety Business Gateway. ✓ Cooperate with market surveillance authorities when requested. For more details, refer to the section 3.1.3. on importer’s obligations.

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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.