Use this workflow when a complaint, test result, accident report, marketplace notice, authority contact, or supplier escalation suggests that a consumer product made available in the EU may be dangerous.
It keeps the triage focused on GPSR duties: incident intake, risk assessment, Safety Business Gateway notification, withdrawal or recall decisions, consumer communications, marketplace coordination, and evidence records.
Structured answer sets in this page tree.
Cited legal and guidance references.
EU GPSR incident and recall triage starts when the team receives safety information about a consumer product: an accident, complaint, test failure, marketplace report, supplier notice, authority request, or monitoring signal. The useful output is not a generic compliance memo; it is a case file showing what product is affected, who is the responsible economic operator or marketplace contact, whether the product is dangerous, what notification or corrective action was taken, what consumers were told, and what evidence supports each decision.
Open a case as soon as the signal alleges a safety issue, accident, or dangerous product. Record the product exactly as it is sold: name, brand, type, model, batch or serial number, barcode, packaging description, images, listing URL, marketplace offer identifier, countries where it was made available, and the economic operators in the supply chain.
Classify the notifier role before anyone submits through the Safety Business Gateway. GPSR accident and dangerous-product notifications are for the concerned economic operators and online marketplace providers; third-party submission is not the ordinary route. If an importer, distributor, fulfilment service provider, marketplace, or responsible person knows the facts before the manufacturer, the case file should show how the manufacturer or responsible person was informed.
The triage owner should separate three questions: what is the defect or safety issue, how that defect can harm consumers, and what evidence supports the risk level. The Safety Business Gateway form expects a risk description, risk category, risk level, and any laboratory, visual test, certificate, or risk-assessment document available.
Do not block notification just because the team has not completed a formal risk assessment. The Safety Business Gateway manual states that determining the risk level is not required for notifying a dangerous product; if the notifier cannot assess the level, the form allows an Unknown risk level. Market surveillance authorities can reach a different conclusion from the notifier's grading.
If the case involves an accident caused by a product, Article 20 requires notification through the Safety Business Gateway without undue delay from when the manufacturer knows about the accident. The notification must include the product type, identification number, and accident circumstances if known; serious health effects, injuries, other bodily damage, illnesses, chronic health effects, or death are within the accident-notification rule.
If the case is a dangerous product rather than an accident, Articles 9, 11, 12, and 22 still drive Safety Business Gateway notifications by manufacturers, importers, distributors, responsible persons, and providers of online marketplaces according to their roles. The case owner should submit with the information available, then keep the Case ID, submission number, PDF copy, translation status, and later updates in the evidence record.
Use Sorena to structure product identity, risk evidence, Gateway submissions, corrective actions, recall notices, marketplace actions, and follow-up records in one cited workflow.
Once the product is treated as dangerous or potentially dangerous, assign a corrective-action owner and decide which measure reduces or eliminates the risk. GPSR distinguishes withdrawal, which prevents a product in the supply chain from being made available, from recall, which aims to achieve return of a product already made available to consumers.
A single case may need more than one action. For example, the team may withdraw unsold inventory, recall units already with consumers, warn consumers about safe use while replacement parts are prepared, and ask marketplaces to remove or disable offers. Keep each action separate with scope, duration, responsible company, start date if available, results, and the consumer-facing message.
When recall information is provided in writing, GPSR Article 36 requires a recall notice that consumers can easily understand in the language of each Member State where the product was made available. The notice should help consumers identify the product, understand the hazard, stop using it, obtain the remedy, and contact the business for more information.
Avoid phrasing that lowers perceived risk. The GPSR and the recall-notice template warn against words such as voluntary, precautionary, discretionary, in rare situations, in specific situations, or statements that there have been no reported accidents. The notice should be accessible and, online, essential identification information shown in pictures should also be available as machine-readable text.
"any update, modification or withdrawal"
"WHY IS THIS PRODUCT DANGEROUS?"
"interoperable interface"
"Each action should be clearly described"
"publishing information on product safety recalls"