{
  "type": "problem",
  "slug": "first-product-launch",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/first-product-launch/",
  "markdown": "https://www.conphora.com/solutions/problem/first-product-launch.md",
  "title": "We are launching our first physical product in the EU",
  "description": "What a first-time manufacturer must have before launch under the GPSR: risk analysis, technical documentation, identification, address, instructions.",
  "answer": "Under the General Product Safety Regulation, a manufacturer places only safe products on the market. Before launch, carry out an internal risk analysis, draw up technical documentation, mark the product with a type or batch number and your name and addresses, add instructions in the local language, and set up a complaints channel. Check first whether a product-specific act such as the Low Voltage Directive applies; its duties replace these.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    }
  ],
  "regulations": [
    "GPSR"
  ],
  "path": [
    "free-compliance-check",
    "regulation-library",
    "track-compliance-manager"
  ],
  "trigger": "The first production run is ordered and the launch date is set, and nobody in the team has placed a product on the EU market before",
  "keep": "Technical documentation for 10 years after the product is placed on the market (GPSR Article 9(3)); personal data in the complaints register no longer than five years after entry (GPSR Article 9(13))",
  "why": [
    {
      "text": "A first launch is mostly about the General Product Safety Regulation, which applies from 13 December 2024 (Article 52) to consumer products insofar as no specific Union provisions with the same objective regulate their safety (Article 2(1)). Its core rule is short: economic operators place or make available on the market only safe products (Article 5). A safe product presents no risk, or only the minimum risks compatible with its use and acceptable with a high level of protection, under normal or reasonably foreseeable conditions of use (Article 3(2)).",
      "sources": [
        1
      ]
    },
    {
      "text": "Check the scope first. If the product falls under a product-specific harmonisation act, the GPSR's manufacturer, importer and distributor duties in Chapter III Section 1 (Articles 9 to 18) do not apply; the sector act sets them instead, often with a conformity assessment and CE marking (Article 2(1)(b)). REACH restrictions and labelling rules do not replace these duties. The GPSR's safety chapter still covers risks the sector act does not (Article 2(1)(a)), and Article 19 on online offers, in Section 2, still applies. The rest of this page describes the route for a product that only the GPSR covers.",
      "sources": [
        1
      ]
    },
    {
      "text": "Before launch, the manufacturer carries out an internal risk analysis and draws up technical documentation with at least a general description of the product and its safety-relevant characteristics; where the risks call for it, the documentation also contains the risk analysis and the solutions adopted, test reports, and the European standards or other elements applied (Article 9(2)). The aspects for the assessment are listed in Article 6(1): the product's characteristics and packaging, its interaction with other products, its presentation, labelling and warnings, the categories of consumers using it, its appearance, and where relevant its cybersecurity and evolving functions. The documentation is kept up to date and available to authorities for 10 years (Article 9(3)).",
      "sources": [
        1
      ]
    },
    {
      "text": "The product itself carries the traceability. It bears a type, batch or serial number visible to consumers (Article 9(5)) and the manufacturer's name, registered trade name or mark and postal and electronic address, on the product or, where that is not possible, on the packaging or an accompanying document (Article 9(6)). It comes with clear instructions and safety information in a language consumers easily understand, as determined by the Member State where it is sold, unless it can be used safely without them (Article 9(7)). Procedures keep series production conforming (Article 9(4)).",
      "sources": [
        1
      ]
    },
    {
      "text": "After launch, the manufacturer listens and acts. It makes public channels available for complaints and accident reports (Article 9(11)), investigates them and keeps an internal register of complaints, recalls and corrective measures (Article 9(12)). If it has reason to believe a product is dangerous, it acts immediately and notifies the authorities through the Safety Business Gateway (Article 9(8)). Online offers carry the manufacturer's details, product identification and warnings in the local language (Article 19), and a product may only be placed on the market if an economic operator established in the Union is responsible for it (Article 16(1)); that operator's name and postal and electronic address appear on the product, its packaging, the parcel or an accompanying document (Article 16(3); Regulation (EU) 2019/1020 Article 4).",
      "sources": [
        1,
        2
      ]
    }
  ],
  "steps": [
    {
      "name": "Find out which rules govern the product",
      "text": "Check whether a Union harmonisation act, such as the Low Voltage or Toy Safety Directive, covers the product. If so, that act sets your duties, and the GPSR manufacturer duties in Articles 9 to 18 do not apply, though its online-offer rules and its safety rules for risks the act does not cover still do. If not, the GPSR sets them, as described below.",
      "item": "free-compliance-check"
    },
    {
      "name": "Carry out the internal risk analysis",
      "text": "Assess the product against the aspects the GPSR names: its characteristics and packaging, its effect on and from other products, its presentation, labels and warnings, the consumers who will use it, including children and older people, its appearance, and where relevant cybersecurity and learning functions.",
      "item": "regulation-library"
    },
    {
      "name": "Write the technical documentation",
      "text": "Before launch, document at least a general description of the product and its safety-relevant characteristics. Where the risks call for it, add the risk analysis and the solutions chosen, test reports, and the European standards or other references you applied, noting any applied only in part. Keep it up to date for 10 years."
    },
    {
      "name": "Mark the product and write the instructions",
      "text": "Give the product a type, batch or serial number visible to consumers. Put your name, registered trade name or mark and your postal and electronic address on the product, or on the packaging or an accompanying document if that is not possible. Add clear instructions and safety information in a language consumers in each target country easily understand."
    },
    {
      "name": "Set up series control and a complaints channel",
      "text": "Put procedures in place so that every unit of the series stays as safe as the one you assessed. Publish a phone number, email address or web form where consumers can report complaints and accidents, investigate the reports and keep an internal register of complaints, recalls and corrective measures.",
      "item": "track-compliance-manager"
    },
    {
      "name": "Prepare the sales channels",
      "text": "Online offers must show your name and addresses, a picture and identifiers of the product, and the warnings and safety information in the local language. If your company is outside the EU, the product also needs an economic operator established in the EU, whose name and contact details appear on the product, packaging, parcel or an accompanying document."
    }
  ],
  "documents": [
    {
      "name": "The internal risk analysis and the technical documentation",
      "from": "The manufacturer",
      "ground": "GPSR Article 9(2) and (3)"
    },
    {
      "name": "Instructions and safety information in the languages of the target countries",
      "from": "The manufacturer",
      "ground": "GPSR Article 9(7)"
    },
    {
      "name": "The internal register of complaints, recalls and corrective measures",
      "from": "The manufacturer",
      "ground": "GPSR Article 9(12)"
    }
  ],
  "risks": [
    {
      "title": "A dangerous product must be recalled",
      "text": "If the manufacturer has reason to believe its product is dangerous, it immediately takes corrective measures, including withdrawal or recall, informs consumers and notifies the authorities through the Safety Business Gateway (GPSR Article 9(8)).",
      "source": 1
    },
    {
      "title": "Importers and retailers will refuse the product",
      "text": "Importers check that the manufacturer met the technical documentation, identification and address duties, and distributors also check the instructions; a product that fails is not placed or made available (GPSR Articles 11(1)–(2) and 12(1) and (3)).",
      "source": 1
    },
    {
      "title": "No EU operator, no market",
      "text": "A product may not be placed on the market unless an economic operator established in the Union is responsible for the tasks in Article 4(3) of Regulation (EU) 2019/1020 for it (GPSR Article 16(1)).",
      "source": 1
    }
  ],
  "faq": [
    {
      "q": "Do we need a test report?",
      "a": "The GPSR does not require a specific test. The technical documentation includes test reports where appropriate for the product's possible risks, together with the standards or other references applied (GPSR Article 9(2)(a) and (b))."
    },
    {
      "q": "Our product needs no instructions to be used safely. Do we still write them?",
      "a": "The instructions and safety information requirement does not apply where the product can be used safely and as intended without them (GPSR Article 9(7))."
    },
    {
      "q": "How long do we keep the documentation?",
      "a": "Ten years after the product is placed on the market, and it is made available to the market surveillance authorities on request (GPSR Article 9(3))."
    },
    {
      "q": "We have one product and one person. Is a complaints register really required?",
      "a": "Yes. Manufacturers investigate safety complaints and accident reports and keep an internal register of those complaints, recalls and corrective measures (GPSR Article 9(12)). The text makes no exception for small manufacturers."
    },
    {
      "q": "When did these rules start?",
      "a": "The GPSR applies from 13 December 2024 (GPSR Article 52)."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EU) 2023/988 on general product safety (consolidated text of 29 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R0988-20260529",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2019/1020 on market surveillance and compliance of products (consolidated text of 12 August 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R1020-20260812",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "which-regulations-apply",
    "needs-ce-marking",
    "language-requirements",
    "label-no-eu-address",
    "complaints-register",
    "sell-in-europe"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}