FAQEU

EU GPSR FAQ Accident notification

Under the EU GPSR, accident reporting is triggered by an accident caused by a product that results in death or serious adverse health and safety effects, not by every complaint or quality issue.

This FAQ helps identify the notifier, the accident threshold, the Safety Business Gateway route, the information to prepare, and the non-public evidence to preserve.

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Author
Sorena AI
Published
May 9, 2026
Updated
Jul 24, 2026
Questions
4

Structured answer sets in this page tree.

Primary sources
2

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 24, 2026
Overview

A GPSR notification is required when an accident caused by a product and associated with its use results in death or serious adverse effects on a person's health and safety. The manufacturer must ensure notification through the Safety Business Gateway without undue delay after learning of the accident. Importers and distributors that know of it must inform the manufacturer, and the responsible person with knowledge of the accident must ensure notification when the manufacturer is not established in the Union.

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4 of 4 questions
Question 1

Who reports a GPSR product accident?

Article 20 puts the primary reporting duty on the manufacturer: it must ensure that the 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 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 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.

  • Assign a reporting owner for the manufacturer or EU responsible person before a serious incident occurs.
  • Route importer, distributor, marketplace, support, and quality-team intake to that owner immediately.
  • Record who first learned of the , when they learned it, and whether the manufacturer, importer, distributor, responsible person, or marketplace provider submitted or escalated the notification.

When must manufacturers report accidents under the EU GPSR?

A manufacturer must ensure notification through the Safety Business Gateway without undue delay from the moment it knows about an caused by a product placed or made available on the market. The notification goes to the competent authorities of the Member State where the accident occurred.

Can an importer or distributor report instead of the manufacturer?

Importers and distributors that know of the must inform the manufacturer without undue delay. The manufacturer either makes the notification itself or instructs the importer or one of the distributors to make it.

Citations
Question 2

What accidents trigger GPSR notification?

The Article 20 threshold is specific. The 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 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.

  • Capture the product use context, the harm alleged or confirmed, and whether the harm involved death, injury, body damage, illness, or chronic health effects.
  • Separate Article 20 triage from ordinary complaint handling, corrective action, recall, and marketplace takedown workflows.
  • Keep unresolved facts visible, including unknown product identifiers, unknown circumstances, or missing medical details.
Citations
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Review your GPSR accident-notification workflow

Map incident intake, Article 20 triage, Safety Business Gateway submission evidence, and responsible-person escalation before a serious product accident is reported.

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Question 3

What goes into the Safety Business Gateway notification?

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

Operationally, prepare the facts before submission: Member State where the 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.

  • Minimum legal content: product type, product identification number, and circumstances if known.
  • Useful internal packet: product master data, complaint or support ticket, photos, incident chronology, injury or health-effect description, sales or batch traceability, and any risk assessment or corrective action record.
  • Submission evidence: gateway case or submission identifier, submitted PDF or confirmation, submitting entity and role, recipient Member State authority, and any follow-up request from authorities.

What information must the GPSR notification include?

Article 20 requires the product type, product identification number, and the circumstances if known. Authorities may also request other relevant information, so teams should preserve the incident chronology, product identifiers, injury details, photos, traceability records, and any corrective-action evidence.

Does the GPSR set a fixed number of days for notification?

No fixed day count is stated in Article 20 for business notification. The cited timing rule is to notify through the Safety Business Gateway without undue delay from the moment the manufacturer knows about the accident, with importer, distributor, and responsible-person escalation also framed as without undue delay.

Citations
Question 4

Internal evidence to keep after notification

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 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 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.

  • intake: source of report, time of knowledge, affected person facts available to the business, product use context, and harm description.
  • Product evidence: type, model, serial or batch identifiers, barcode, photos, sales channel, country or Member State facts, and traceability records.
  • Decision trail: Article 20 threshold assessment, reporting actor, Safety Business Gateway submission evidence, authority follow-up, manufacturer or responsible-person instructions, and any importer, distributor, or marketplace escalation.
Citations
Primary sources

References and citations

European Commission Safety Business Gateway
webgate.ec.europa.eu
Referenced sections
  • Commission gateway page supports preserving Safety Business Gateway submission evidence for dangerous-product and accident reports.
"National authorities may use the information submitted"
Regulation (EU) 2023/988 on general product safety
eur-lex.europa.eu
Referenced sections
  • Article 20 supports keeping evidence around knowledge timing, product identification, accident circumstances, and requested follow-up information.
"from the moment it knows about the accident"
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