{
  "type": "problem",
  "slug": "documents-scattered",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/documents-scattered/",
  "markdown": "https://www.conphora.com/solutions/problem/documents-scattered.md",
  "title": "Our compliance documents are scattered everywhere",
  "description": "Test reports in mailboxes, declarations on a shared drive: how to bring compliance files into one current, retrievable record per product model.",
  "answer": "EU product law expects the manufacturer to keep the technical documentation up to date and available to authorities for 10 years, and the EU-based operator to produce it on request. Authorities may demand documents wherever and however they are stored. Collect every file under one record per product model, name an owner, mark the current version, and test that you can produce a complete file within days.",
  "theme": {
    "id": "documentation",
    "label": "Documentation and declarations"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "GPSR",
    "LVD"
  ],
  "path": [
    "product-validation",
    "documentation-generator",
    "compliance-status-links"
  ],
  "trigger": "A request for one product's documents takes days of searching through mailboxes, shared drives and supplier portals",
  "keep": "Technical documentation and the EU declaration of conformity for 10 years after the product has been placed on the market (GPSR Article 9(3); Directive 2014/35/EU Article 6(3)); importers keep a copy of the GPSR technical documentation for 10 years after they placed the product on the market (GPSR Article 11(6))",
  "why": [
    {
      "text": "Scattered files are not a legal category, but the duties they put at risk are. Under the General Product Safety Regulation (EU) 2023/988, the manufacturer carries out an internal risk analysis and draws up technical documentation before placing a product on the market (Article 9(2)). It must ensure the documentation is up to date, keep it at the disposal of market surveillance authorities for 10 years after the product has been placed on the market, and make it available on request (Article 9(3)). Importers keep a copy for 10 years after they placed the product on the market (Article 11(6)). Under Article 2(1), third subparagraph, point (b), Chapter III Section 1, which holds these articles, does not apply to products subject to Union harmonisation legislation; for those products the act's own file rules apply.",
      "sources": [
        1
      ]
    },
    {
      "text": "The CE directives set the same pattern. Under the Low Voltage Directive 2014/35/EU the manufacturer draws up the technical documentation in Annex III and keeps it with the EU declaration of conformity for 10 years (Article 6(2) and (3)). Annex III point 4.2 asks for the declaration to be drawn up for a product model and kept together with the technical documentation. On a reasoned request the manufacturer provides all information and documentation, in paper or electronic form, needed to demonstrate conformity (Article 6(9)). An importer keeps a copy of the declaration and ensures the technical documentation can be made available (Article 8(8)).",
      "sources": [
        2
      ]
    },
    {
      "text": "The person who answers the authority is often not the person who holds the files. For products under the acts listed in Article 4(5) of Regulation (EU) 2019/1020, a product may be placed on the market only if an EU-based economic operator is responsible for verifying that the declaration and the technical documentation have been drawn up, keeping the declaration available and ensuring the file can be made available on request (Article 4(1) and (3)(a)). That operator also provides the documentation in a language the authority easily understands (Article 4(3)(b)). For GPSR products whose manufacturer is outside the Union, the responsible economic operator also checks regularly, where appropriate to the risks, that the product conforms with the technical documentation, and, on request by the market surveillance authorities, provides documented evidence of the checks performed (GPSR Article 16(2)).",
      "sources": [
        3,
        1
      ]
    },
    {
      "text": "Authorities do not have to wait for you to find the files. Article 14(4)(a) of Regulation (EU) 2019/1020 gives them the power to require documents and data on compliance in any form or format, irrespective of the medium of storage or the place where they are stored, and to take copies. If the evidence cannot be produced, the authority can require corrective action, including rectifying formal non-compliance, and ensure withdrawal, recall or a prohibition when the operator does not act (Article 16(3) and (5)).",
      "sources": [
        3
      ]
    }
  ],
  "steps": [
    {
      "name": "Make one record per product model",
      "text": "Start a register keyed by the model or type number that appears on the product. Each record gets the applicable acts, the declaration, the test reports, the risk analysis, the instructions and labels, and supplier certificates. A file that cannot be tied to a model number is not yet evidence.",
      "item": "product-validation"
    },
    {
      "name": "Sweep the places where files hide",
      "text": "Search mailboxes of purchasing and quality staff, shared drives, supplier portals and test lab accounts. Move or link each file into the model record. Keep the original e-mail or download date, because it shows when you received the evidence."
    },
    {
      "name": "Mark the current version and archive the rest",
      "text": "For each document type, mark one version as current and keep earlier versions archived, not deleted. The file must stay up to date, but you also need to show what applied to units placed on the market earlier.",
      "item": "documentation-generator"
    },
    {
      "name": "Name an owner and a retrieval route",
      "text": "Give each product family an owner. Make sure the EU-based operator, such as your importer or authorised representative, can reach the file without asking one person. Write down who sends what to an authority and in which language."
    },
    {
      "name": "Run a retrieval test",
      "text": "Pick a model at random and assemble its complete file as if an authority had asked. Time it. Every gap you find, such as a missing test report or an unsigned declaration, goes on a list with a date for closing it.",
      "item": "compliance-status-links"
    }
  ],
  "documents": [
    {
      "name": "A product register with one record per model and its document status",
      "from": "Your own compliance records",
      "ground": "GPSR Article 9(2)–(3); Directive 2014/35/EU Article 6(2)–(3)"
    },
    {
      "name": "The current technical documentation and declaration for each model, with earlier versions archived",
      "from": "The manufacturer",
      "ground": "GPSR Article 9(3); Directive 2014/35/EU Annex III point 4.2"
    },
    {
      "name": "A note of who holds the file for the EU-based operator and how it is supplied",
      "from": "The manufacturer, importer or authorised representative",
      "ground": "Regulation (EU) 2019/1020 Article 4(3)(a)–(b)"
    }
  ],
  "risks": [
    {
      "title": "Authorities can ask for documents wherever they are",
      "text": "Market surveillance authorities have the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance in any form or format and irrespective of the medium of storage or the place where they are stored (Regulation (EU) 2019/1020 Article 14(4)(a)).",
      "source": 3
    },
    {
      "title": "An outdated file breaks the duty itself",
      "text": "Manufacturers must ensure the technical documentation is up to date and keep it at the disposal of market surveillance authorities for 10 years after the product has been placed on the market (GPSR Article 9(3)). The low voltage directive sets the same 10 years for CE-marked electrical equipment (Directive 2014/35/EU Article 6(3)).",
      "source": 1
    },
    {
      "title": "Missing documents become a formal non-compliance",
      "text": "Authorities require corrective action, which may include rectifying formal non-compliance, and ensure withdrawal, recall or a prohibition where the operator does not act (Regulation (EU) 2019/1020 Article 16(3)(a) and (5)).",
      "source": 3
    }
  ],
  "faq": [
    {
      "q": "Can we keep the technical documentation in electronic form only?",
      "a": "The low voltage directive lets the manufacturer provide information and documentation to an authority in paper or electronic form (Directive 2014/35/EU Article 6(9)). Authorities can require documents in any form or format (Regulation (EU) 2019/1020 Article 14(4)(a))."
    },
    {
      "q": "Is a supplier's portal good enough as our archive?",
      "a": "The duty to keep the file sits with the manufacturer, and with the importer for its copy (GPSR Articles 9(3) and 11(6); Directive 2014/35/EU Articles 6(3) and 8(8)). If the supplier closes the portal, your evidence goes with it, so keep your own copy."
    },
    {
      "q": "Who must be able to produce the file for a product made outside the EU?",
      "a": "For products under the acts listed in Article 4(5) of Regulation (EU) 2019/1020, the EU-based operator: the importer, an authorised representative or, where no other is established in the EU, a fulfilment service provider. It verifies that the declaration and technical documentation exist and ensures the file can be made available on request (Article 4(2)–(3))."
    },
    {
      "q": "How is this different from having no documentation at all?",
      "a": "Here the documents exist but cannot be found or trusted quickly. The work is collecting, versioning and owning them. Where a model has no file at all, the gap is rebuilding it, which is a separate task."
    }
  ],
  "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": "Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0035-20260530",
      "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": [
    "no-technical-documentation",
    "authority-asks-technical-file",
    "keep-documents-how-long",
    "employee-left",
    "retailer-proof"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}