Within how many working days must I report a serious product incident under GPSR?

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Jason van de Zande

Under the General Product Safety Regulation (EU) 2023/988 (GPSR), a serious product accident must be notified to the competent authorities without undue delay and, in any event, within two working days after the responsible economic operator becomes aware of it. The two-day clock starts when you know that the accident is serious and linked to your product. Below are the practical rules for counting working days, what “serious” means, and how to report correctly.

Within how many working days must a serious product incident be reported under the GPSR?

A serious product accident must be reported within two working days under the GPSR, and you should notify without undue delay even if some details are still being confirmed. In practice, “working days” means business days, excluding weekends and public holidays in the relevant Member State authority’s calendar. The clock starts when the relevant economic operator becomes aware of the serious accident and its link to the product.

Do not wait for a full internal investigation before notifying. You can submit an initial notification and then provide follow-up information as it becomes available. Build an internal trigger so that customer support, quality, and legal teams escalate any potentially serious product accident immediately, including accidents reported via online marketplaces.

What counts as a serious product incident under the GPSR?

Under the GPSR, a product accident is “serious” when it involves outcomes such as death or serious injury, or when it indicates a significant risk to health and safety that may require rapid action. The assessment is risk-based, looking at severity, likelihood, and who is exposed, including vulnerable users such as children. When in doubt, precautionary reporting is often the safer compliance choice.

It helps to distinguish between common inputs:

  • Accident: harm occurred, for example, burns, choking, electric shock, poisoning.
  • Near miss: no harm, but a credible potential for serious harm under foreseeable use.
  • Complaint: dissatisfaction or a minor defect report, not necessarily safety-related.

A single serious accident can be enough to trigger notification, especially if it suggests a design, manufacturing, labeling, or instructions issue that could affect other units on the EU market.

How do you report a serious product incident under the GPSR in practice?

To report a serious product accident in practice, act fast, preserve evidence, identify the exact product and batch, assess the risk, and then notify the competent authority through the appropriate channel, commonly via Safety Gate tools where applicable. Provide clear facts: what you know now and what you are doing next. Keep records of the notification, internal decisions, and any corrective measures.

  1. Secure evidence: photos, videos, returned product, packaging, and user statements.
  2. Identify traceability: model, SKU, batch or serial number, EAN, listing URL, and where it was sold.
  3. Run a rapid risk assessment: hazard, severity, foreseeable use or misuse, affected users.
  4. Notify the authority: submit an initial report within two working days, then update it.
  5. Control the risk: stop shipments if needed, correct instructions, warnings, or design, and prepare corrective actions, including recall steps if required.
  6. Document everything: keep a clear audit trail, including communications across the supply chain and with online marketplaces.

Also align your actions with Market Surveillance Regulation (EU) 2019/1020 (MSR) obligations on cooperation and information flows between economic operators, since authorities may request documentation and traceability data quickly.

How does EARP help with GPSR serious incident reporting?

We help you meet GPSR serious product accident reporting obligations with a structured, authority-ready process that reduces delays and avoids incomplete submissions. Our support is practical and documentation-focused, so your team can act quickly while keeping control of the facts and decisions.

  • Accident triage to confirm whether the event is likely “serious” and what information is missing.
  • Drafting and review of notifications so they are consistent, clear, and complete for authority intake.
  • Liaison support to manage communications and follow-up requests from market surveillance authorities.
  • Document management to organize and retrieve technical files and traceability data efficiently when requested.
  • Ongoing compliance processes aligned with our broader services for EU market access under GPSR and MSR.

If you need help handling a serious product accident notification or setting up an internal reporting workflow, contact us here: contact.

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