D)

Keep the manufacturer informed of any accident caused by a product and ensure that the 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 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 this 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 concern occurrences associated with the use of a product that resulted in an individual’s death or in serious adverse effects on an 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. Check list for the distributor Before making the product available on the market: ✓ Verify that the product identification details, the manufacturer’s and importer’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. ✓ Verify that no labels obscure any other mandatory information. ✓ Ensure that storage or transport does not affect product safety or its labelling. ✓ Set up internal processes for product safety. ✓ Display the required product information in distance sales offers: — product identification details and its picture, — identification and contact details of the manufacturer, — identification and contact details of the responsible person for the product in the EU, — instructions and safety information if needed. ✓ If you have a registration scheme or a customer loyalty programme in place, you must offer the possibility for consumers to subscribe for safety-related purposes only. ✓ Don’t make a non-conform or dangerous product available on the market! In case of any non-compliance inform the manufacturer and authorities. After making the product available on the market: ✓ If a product you made available is dangerous or non-compliant: — Inform the manufacturer or the importer — Ensure the manufacturer or importer have taken necessary corrective measures (for recalls ensure that they used the template recall notice and provided remedies). — Ensure that national authorities are immediately informed via the Safety Business Gateway. If they have not been informed by the manufacturer or importer, do it. — Manufacturer and importer must inform consumers about dangerous products. Be cooperative and proactive in the information dissemination. ✓ 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 3.1.4. on distributor’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.