Accident Reporting under the GPSR
Understand your responsibilities when safety events and accidents arise that are related to your products and how to remain compliant with the General Product Safety Regulation (EU) 2023/988 (GPSR). Failing to report can lead to safety alerts, recalls, product bans, and reputational damage.
At EARP, we support our clients as Authorized Representative (AR) and Responsible Person (RP) where we play an important role in compliance of the products to applicable EU regulations and act as the official contact point for product safety inquiries and follow-up on notifiable events, as well as act as a liaison between the manufacturer and national inspection and surveillance authorities.
ANSWERED ON THIS PAGE
- What counts as a “reportable accident”
- Who is responsible for reporting and when
- What to include in a notification
- How EARP supports
What counts as a “reportable accident”
Under Article 20(1) of the GPSR, manufacturers must notify authorities without undue delay if they become aware of a product-related accident an occurrence caused by a product that results in death or serious adverse effects on health, including injuries or chronic conditions. This requirement applies regardless of how the product is sold online, in-store, or through a fulfillment service.
Online marketplaces have their own obligations. Under Article 22(12), they must report serious risks, even if no harm is yet occurred. A serious risk refers to a potential danger even without an actual accident. This means a product that could cause foreseeable harm must still be flagged by the platform.
Who reports and when
The manufacturer is always primarily responsible for assessing and reporting accidents (GPSR Article 20(1)) and the report must be submitted without undue delay. But if the manufacturer is located outside the EU and does not act, the Responsible Person, such as EARP, must ensure a notification to authorities is made once aware of the accident (Article 20(4)).
What to include in a notification
Notifications must be submitted via the EU Safety Business Gateway and should include:
- Manufacturer information: The manufacturer’s name, registered trade name or trademark, and contact details (postal and email address).
- Product identification: A unique identifier for the product, such as a type, batch, or serial number.
- Product description: A description of the product, including an image.
- Incident summary: Location, time, nature of the injury or damage
- Risk assessment: Explanation of hazard and estimated level of risk
- Prior reporting history: Confirmation if previously reported
- Actions taken or planned
- If already determined and applicable, outline of corrective and preventive action and measures
An accident must be notified to the authorities of the Member State where the accident occurred. Authorities may follow up for further investigation or require or issue public alerts.
Work as a closed loop
Describe the product (with identifiers and an image), summarize what happened (time, place, harm), explain the hazard and your risk estimate, and state the measures taken or planned (withdrawal, recall, consumer notice). Add distribution details (countries/quantities if available) and reference any earlier submissions. If your case evolves, send follow-ups to keep authorities aligned.
Maintaining proper documentation, including consumer complaints, design control, risk assessment, technical documentation, and corrective and preventive action (CAPA) procedures. These are essential for demonstrating compliance during audits or when responding to requests from market surveillance authorities.
How EARP supports
EARP helps clients prepare for this process by outlining what documentation should be maintained and by offering guidance on how to prepare for potential authority follow-up. This is particularly useful for non-EU companies unfamiliar with EU requirements concerning safety events.
As your Authorized Representative and Responsible Person, EARP provides:
- A direct reporting channel on your product labeling, meeting GPSR Article 16(3)
- Safety issue intake and triage, ensuring reports are logged and forwarded in a timely manner
- Notification of the manufacturer and assistance in evaluating whether a reported event meets the threshold for notification
- Guide and support manufacturer with drafting and review of notifications
Read more about EARP’s Representation services. If you need to report a safety issue concerning a product that is represented by EARP, you can submit details via EARP’s online reporting form so our team can assess the case and advise on next steps.
We do not replace the manufacturer’s post-market surveillance responsibilities including internal safety monitoring and documentation but we step in if required to ensure regulatory compliance.
The EU Safety Business Gateway is the European Commission’s platform for submitting product safety notifications to national market surveillance authorities. It ensures that competent authorities are promptly informed when a product-related accident results in serious harm.
Manufacturers must report actual accidents that result in death or serious harm but also take appropriate action to prevent identified safety risk with the product. Online marketplaces must also report serious risks, even if no injury occurred.
Yes. Even if an complaint or event is not reportable, you must keep records of consumer complaints and issues identified with the product Complaint Records may be requested by market surveillance authorities under Article 19 of the GPSR.
Yes. Through the Safety Business Gateway, required information for a notification is requested in a structured manner. EARP provides guidance and can share templates to support timely notifications.
Yes. The manufacturer remains ultimately responsible, but the Responsible Person (RP), such as EARP, can submit accident notifications on your behalf, as required under Article 20(4) of the GPSR. This is particularly relevant if the manufacturer is located outside the EU.
