{
  "type": "problem",
  "slug": "customer-injured",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/customer-injured/",
  "markdown": "https://www.conphora.com/solutions/problem/customer-injured.md",
  "title": "A customer was injured by our product",
  "description": "What the GPSR requires after an accident: notify the authority through the Safety Business Gateway, investigate the complaint and decide what to correct.",
  "answer": "Under the General Product Safety Regulation (EU) 2023/988, the manufacturer must notify an accident caused by its product, without undue delay from the moment it knows about it, to the competent authorities of the Member State where the accident happened, through the Safety Business Gateway. Importers and distributors inform the manufacturer without undue delay. Then investigate the complaint, record it, and decide whether the product needs corrective measures.",
  "theme": {
    "id": "incidents-recalls",
    "label": "Incidents, recalls and authorities"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "GPSR"
  ],
  "path": [
    "recall-manager",
    "regulation-library"
  ],
  "trigger": "A consumer, a retailer, a hospital or a lawyer tells you that someone was hurt while using your product",
  "keep": "Personal data in the complaint register no longer than five years after entry (GPSR Articles 9(13) and 11(11)); the description of risks, complaints, accidents and corrective measures must be presentable for 10 years after you were supplied with or supplied the product (GPSR Article 15(4))",
  "why": [
    {
      "text": "The General Product Safety Regulation (EU) 2023/988 has an article for exactly this situation. Article 20 requires the manufacturer to ensure that an accident caused by a product placed or made available on the market is notified, through the Safety Business Gateway and without undue delay from the moment it knows about the accident, to the competent authorities of the Member State where the accident occurred. The notification includes the type and identification number of the product and the circumstances of the accident, if known; the authority can ask for any other relevant information afterwards.",
      "sources": [
        1
      ]
    },
    {
      "text": "The duty sits with the manufacturer, but the knowledge often sits elsewhere. Importers and distributors who learn of an accident inform the manufacturer without undue delay, and the manufacturer either notifies or instructs the importer or one of the distributors to do it. Where the manufacturer is not established in the Union, the responsible person who knows of the accident ensures that the notification is made (Article 20(3) and (4)).",
      "sources": [
        1
      ]
    },
    {
      "text": "An accident is also a complaint. Manufacturers investigate complaints and accident information that concern the safety of their products, and keep an internal register of complaints, recalls and corrective measures (Article 9(12)); importers do the same (Article 11(10)). The register may hold only the personal data the investigation needs, for no longer than five years after the data were entered (Articles 9(13) and 11(11)).",
      "sources": [
        1
      ]
    },
    {
      "text": "Whether the product must be corrected is a separate decision. A manufacturer who considers, or has reason to believe, that a product it placed on the market is dangerous must immediately take corrective measures, inform consumers and inform the authorities of the Member States where the product was made available (Article 9(8)). On request, every economic operator provides the authority with a full description of the risk, related complaints and known accidents, and of any corrective measure taken (Article 15(2)).",
      "sources": [
        1
      ]
    },
    {
      "text": "Market surveillance itself runs under Regulation (EU) 2019/1020, whose provisions on market surveillance the GPSR applies in part to consumer products (Article 23(1)). Where an operator does not act, the authority ensures the product is withdrawn or recalled and informs the public (Regulation (EU) 2019/1020, Article 16(5)). Compensation for the injury is a separate matter of product liability law: Directive (EU) 2024/2853 applies to products placed on the market or put into service from 9 December 2026, and national law implementing Directive 85/374/EEC to earlier products.",
      "sources": [
        2
      ]
    }
  ],
  "steps": [
    {
      "name": "Secure the facts and the product",
      "text": "Write down what happened, when and where, and which product was involved: type, batch or serial number, and the circumstances of use. Ask for the unit and keep it as it is. The notification will need the type and identification number and the circumstances, so collect them before anything else."
    },
    {
      "name": "Notify the accident through the Safety Business Gateway",
      "text": "The manufacturer notifies the competent authorities of the Member State where the accident occurred, without undue delay from the moment it knows. If you are the importer or a distributor, inform the manufacturer without undue delay; the manufacturer notifies, or instructs you to do it. Where the manufacturer is outside the EU, the responsible person makes sure the notification is made."
    },
    {
      "name": "Investigate the complaint and record it",
      "text": "Manufacturers and importers must investigate complaints and accident information that concern the safety of their products, and keep an internal register of complaints, recalls and corrective measures. Store only the personal data the investigation needs."
    },
    {
      "name": "Decide whether the product is dangerous",
      "text": "Assess the product against the aspects the regulation names: its characteristics, its presentation and warnings, the consumers who use it, and how it is foreseeably used. If you have reason to believe it is dangerous, corrective measures, information to consumers and a notification of the measures follow immediately.",
      "item": "recall-manager"
    },
    {
      "name": "Keep the rest of the chain informed",
      "text": "Other economic operators, responsible persons and marketplaces in the supply chain must be kept informed in a timely manner of any safety issue you identify. Be ready to give the authority a full description of the risk, related complaints and known accidents on request."
    }
  ],
  "documents": [
    {
      "name": "The accident notification",
      "from": "The manufacturer, or the operator it instructs, in the Safety Business Gateway",
      "ground": "GPSR Article 20(1)"
    },
    {
      "name": "The register entry for the complaint",
      "from": "The manufacturer or importer's internal register",
      "ground": "GPSR Articles 9(12) and 11(10)"
    },
    {
      "name": "The risk assessment",
      "from": "Your own investigation, against the Article 6 aspects",
      "ground": "GPSR Articles 6 and 9(8)"
    },
    {
      "name": "Technical documentation",
      "from": "The manufacturer, with the internal risk analysis",
      "ground": "GPSR Article 9(2)"
    },
    {
      "name": "A description of the risk, complaints, accidents and corrective measures",
      "from": "You, on request of a market surveillance authority",
      "ground": "GPSR Article 15(2)"
    }
  ],
  "risks": [
    {
      "title": "The authority takes the corrective measure for you",
      "text": "If the economic operator fails to take corrective action, or the risk persists, market surveillance authorities ensure that the product is withdrawn or recalled, or its being made available is prohibited or restricted, and inform the public (Regulation (EU) 2019/1020, Article 16(5), applied by GPSR Article 23(1)).",
      "source": 2
    },
    {
      "title": "The authority sets the pace",
      "text": "Market surveillance authorities may request regular progress reports and decide whether or when a corrective measure can be considered completed (GPSR Article 15(6)).",
      "source": 1
    },
    {
      "title": "Penalties under national law",
      "text": "Each Member State lays down effective, proportionate and dissuasive penalties for infringements of the regulation (GPSR Article 44).",
      "source": 1
    }
  ],
  "faq": [
    {
      "q": "Which incidents count as an accident that must be notified?",
      "a": "Occurrences associated with the use of a product that resulted in death or in serious adverse effects on health and safety, permanent or temporary, including injuries, other damage to the body, illnesses and chronic health effects (GPSR Article 20(2)). Other safety complaints are investigated and go into the register (Articles 9(12) and 11(10))."
    },
    {
      "q": "We are the importer. Do we notify the authority ourselves?",
      "a": "You inform the manufacturer without undue delay. The manufacturer makes the notification, or instructs the importer or one of the distributors to make it (GPSR Article 20(3))."
    },
    {
      "q": "Which country's authority do we notify?",
      "a": "The competent authorities of the Member State where the accident occurred (GPSR Article 20(1)). Corrective measures are notified to the Member States where the product was made available (Article 9(8))."
    },
    {
      "q": "Does an accident notification mean we have to recall?",
      "a": "No. The accident notification and the corrective measure are separate duties. Whether a withdrawal or recall is needed follows from your assessment of whether the product is dangerous."
    },
    {
      "q": "May we keep the customer's details in our register?",
      "a": "Only the personal data necessary to investigate the complaint, and no longer than five years after the data were entered (GPSR Articles 9(13) and 11(11))."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EU) 2023/988 on general product safety",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/eli/reg/2023/988/oj",
      "accessed": "2026-09-27"
    },
    {
      "title": "Regulation (EU) 2019/1020 on market surveillance and compliance of products",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/eli/reg/2019/1020/oj",
      "accessed": "2026-09-27"
    },
    {
      "title": "Safety Business Gateway — report dangerous products and accidents to the Member State authorities",
      "publisher": "European Commission",
      "url": "https://webgate.ec.europa.eu/safety-business-gateway/screen/public/home",
      "accessed": "2026-09-27"
    }
  ],
  "related": [
    "safety-complaint",
    "safety-business-gateway",
    "withdrawal-or-recall",
    "recall"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}