EU GPSR FAQ Accident notification

Article 20 puts the primary reporting duty on the manufacturer: it must ensure that the accident is notified through the Safety Business Gateway to the competent authorities of the Member State where the accident occurred.

Importers and distributors that know of an accident caused by a product they placed or made available on the market must inform the manufacturer without undue delay. The manufacturer then makes the notification or instructs the importer or one of the distributors to make it.

If the manufacturer is not established in the Union, the responsible person with knowledge of the accident must ensure that the notification is made. Providers of online marketplaces also have a separate GPSR cooperation duty to notify, through the Safety Business Gateway, accidents they have been informed of that resulted in a serious risk or actual consumer health or safety damage, were caused by a product, and involved a product made available on their online marketplace.

The Article 20 threshold is specific. The accident must be caused by the product, the occurrence must be associated with use of the product, and it must have resulted in a person's death or in serious adverse effects on that person's health and safety.

The regulation says serious adverse effects can be permanent or temporary and includes injuries, other damage to the body, illnesses, and chronic health effects. Do not treat every complaint, return, minor dissatisfaction, or unverified defect report as an Article 20 accident unless the facts meet the causality and harm thresholds.

If the facts are incomplete, preserve the intake record and escalate for a cited assessment instead of inventing a day count, national procedure, or risk classification.

Article 20 requires the notification to include the type and identification number of the product and the circumstances of the accident, if known. Competent authorities may request other relevant information.

Operationally, prepare the facts before submission: Member State where the accident occurred, notifier role and contact details, product category, brand, model or type number, barcode or other identifier, affected quantity if known, country of origin if known, a short product description, photos or supporting documents where available, accident consequence, injury details, how the product was used, accident date if known, and corrective actions already taken or planned.

The Safety Business Gateway is the business reporting route; it is not a public complaint form for unrelated third parties. The Commission gateway states that third-party notification by parties not concerned by the product is prohibited.

Keep an evidence record that lets product safety, legal, quality, support, and regulatory teams reconstruct the reporting decision without relying on memory. The record should show why the incident did or did not meet the Article 20 accident threshold and who was responsible for each escalation step.

Preserve both submitted and not-yet-known facts. Article 20 expressly allows circumstances to be reported if known, and authorities can request other relevant information. A clear unknowns log is therefore better than filling gaps with unsupported assumptions.

If a serious accident also triggers a dangerous-product assessment, corrective action, safety warning, marketplace notice, or recall workstream, cross-link those records without merging the legal basis for each obligation.