Do I have to notify Safety Gate if someone is injured using my product?

If someone is injured while using your product, you do not usually “notify Safety Gate” directly. Safety Gate is the EU’s rapid alert system through which authorities share information about dangerous non-food products. Under the General Product Safety Regulation (EU) 2023/988 (GPSR), businesses generally notify the competent national market surveillance authorities—often via the Safety Business Gateway—when they know a product presents a risk. An injury can trigger reporting, but the key question is whether it indicates a product safety risk.

Do I have to notify Safety Gate if someone is injured using my product?

In most cases, no—you do not notify Safety Gate itself. Safety Gate is the EU Rapid Alert System used by authorities, and an alert is typically published by an authority after it receives and validates information. Under the GPSR, when you know, or have reason to believe, that a product you made available in the EU is dangerous, you must notify the competent national market surveillance authorities without undue delay; they may then publish an alert on Safety Gate.

An injury alone does not automatically mean the product is “dangerous” under EU law. You should assess whether the injury points to a safety defect, a reasonably foreseeable misuse that was not adequately addressed, or a broader risk to consumers. Also check which EU framework applies—for example, the GPSR for most consumer products and sector-specific rules for particular categories.

When does an injury become a reportable product safety risk in the EU?

An injury becomes reportable when it suggests the product presents a risk to health or safety, not merely because harm occurred. Under the GPSR, you should treat an injury as a strong signal to carry out a documented risk assessment and decide whether corrective action and notification to the authorities are needed. The more severe the harm and the more likely it is to recur, the more likely it is reportable.

Severity: serious harm, vulnerable users (children, the elderly), or hazards such as choking, burns, or electric shock.
Probability: could the same failure happen again under normal or reasonably foreseeable use?
Foreseeable misuse: common user behavior that should have been anticipated in the design or instructions.
Pattern: similar complaints, returns, or multiple injuries across batches or variants.
Exposure: how many units are in consumers’ hands, and in which EU countries.

Immediate practical steps often include placing stock on hold, stopping shipments, preserving the product and packaging involved, capturing photos and user statements, and checking whether warnings and instructions were clear and provided in the correct local languages. Record your reasoning, even if you conclude the risk is not reportable.

How do I report a dangerous product to EU authorities and what information is needed?

You generally report a dangerous product to EU authorities by notifying the competent national market surveillance authority in each affected Member State, often through the Safety Business Gateway. Under the GPSR, notification should be made without undue delay once you identify a danger and the measures taken or planned. Authorities may use your submission to create a Safety Gate alert if the criteria are met.

Identify where the product was made available (countries, channels, marketplaces).
Notify the relevant authority or authorities, and coordinate messaging across Member States.
Provide a clear risk description and the corrective measures (warning, withdrawal, recall).
Keep an internal register of complaints and corrective measures, and retain supporting records.

Information typically requested includes product identifiers (model, batch, barcode, photos), manufacturer and supply-chain details, quantities and distribution countries, an accident description, your risk assessment, test results (if available), and the consumer-facing actions you are taking. If you have an EU responsible person under the Market Surveillance Regulation (EU) 2019/1020 (MSR), that economic operator must be informed of risks so it can notify the manufacturer under Article 4 of the MSR.

How EARP helps with Safety Gate and EU product incident reporting?

We help you move from “a customer was injured” to a controlled, documented GPSR response that authorities and marketplaces can understand. Our role is to support fast, accurate decision-making and communication, including when a Safety Gate publication may follow authority validation.

Triage product accidents and organize evidence, traceability, and document readiness.
Perform or coordinate risk assessments aligned with GPSR expectations.
Prepare authority notifications and supporting files, including Safety Business Gateway-ready content.
Liaise with national market surveillance authorities and manage follow-up questions.
Support corrective actions, including documentation for withdrawal and recall communications.

See our services to understand how we can support your EU compliance workflow, or contact us to discuss your product accident and the next steps.

Do I have to notify Safety Gate if someone is injured using my product?