{
  "type": "problem",
  "slug": "product-change-recheck",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/product-change-recheck/",
  "markdown": "https://www.conphora.com/solutions/problem/product-change-recheck.md",
  "title": "We changed the product. Does our compliance still hold?",
  "description": "What EU rules say about design changes: series production, updated technical files and declarations, and when a change makes you the manufacturer.",
  "answer": "EU product acts require manufacturers to take changes in design, characteristics and the applied standards adequately into account, and to keep the technical documentation up to date. Under the GPSR, a substantial modification by anyone other than the manufacturer makes that person the manufacturer. List what changed, compare it with the original risk analysis, re-test where the change touches a requirement, and update the documentation and declaration.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "GPSR",
    "LVD",
    "EMC",
    "RED"
  ],
  "path": [
    "product-validation",
    "documentation-generator"
  ],
  "trigger": "A component, supplier, material, firmware version or feature changes on a product that is already on the market with a declaration and test reports",
  "keep": "Technical documentation and the EU declaration of conformity for 10 years after the product is placed on the market (GPSR Article 9(3); Directive 2014/53/EU Article 10(4))",
  "why": [
    {
      "text": "A declaration of conformity describes the product as it was assessed. EU product law does not freeze the product, but it does require the manufacturer to keep the assessment in step with it. The General Product Safety Regulation (GPSR) asks manufacturers to carry out an internal risk analysis and draw up technical documentation before placing a product on the market (Article 9(2)), to keep that documentation up to date and available for 10 years (Article 9(3)), and to have procedures so that products made in series stay in conformity with the general safety requirement (Article 9(4)). Where the manufacturer is outside the Union, the responsible economic operator under Article 16 must also check regularly, where appropriate to the risks, that the product conforms with the technical documentation and Article 9(5) to (7), and, on request by the market surveillance authorities, provide documented evidence of the checks performed (Article 16(2)).",
      "sources": [
        1
      ]
    },
    {
      "text": "The CE directives say the same thing in more detail. Under the Low Voltage Directive, changes in product design or characteristics and changes in the harmonised standards by reference to which conformity is declared shall be adequately taken into account (Directive 2014/35/EU Article 6(4)). The EMC Directive (Article 7(4)) and the Radio Equipment Directive (Article 10(5)) use the same wording. The radio directive adds that the technical documentation is drawn up before the equipment is placed on the market and continuously updated (Article 21(2)), and that the EU declaration of conformity is continuously updated too (Article 18(2)).",
      "sources": [
        2,
        3,
        4
      ]
    },
    {
      "text": "The law does not list which changes need new tests. It leaves that to the manufacturer's assessment, which is why the reasoning matters as much as the result. The GPSR gives a useful test for when a change becomes substantial: a modification by physical or digital means that affects safety, was not foreseen in the initial risk assessment, and changes the nature of the hazard, creates a new one or increases the risk, unless consumers made it for their own use (Article 13(3)).",
      "sources": [
        1
      ]
    },
    {
      "text": "That test also decides who carries the responsibility. A person other than the manufacturer that substantially modifies a product is deemed a manufacturer and takes on the obligations of Article 9 for the affected part, or for the entire product if the modification affects its safety (GPSR Article 13(2)). The Machinery Regulation, which applies from 20 January 2027, has a similar rule for machinery: the person who carries out a substantial modification is considered the manufacturer and applies the relevant conformity assessment procedure itself, unless a non-professional user modifies the machine for their own use (Regulation (EU) 2023/1230 Articles 3(16), 18 and 54; the date of application was corrected from 14 to 20 January 2027 by a corrigendum published on 4 July 2023).",
      "sources": [
        1,
        5
      ]
    },
    {
      "text": "When a change leaves a product out of conformity, the duty to correct follows. Under the Radio Equipment Directive the manufacturer must immediately bring non-conforming equipment into conformity, withdraw it or recall it (Article 10(11)), and an authority that finds the technical documentation insufficient may order a test at the manufacturer's or importer's expense (Article 21(4)).",
      "sources": [
        4
      ]
    }
  ],
  "steps": [
    {
      "name": "List what actually changed",
      "text": "Write down every change since the last assessment: components and their suppliers, materials, firmware and software, ratings, packaging, instructions and the uses you now market. Include digital changes; the GPSR counts modifications made by physical or digital means. Note the date and the first serial or batch number with the change."
    },
    {
      "name": "Compare each change with the original risk analysis",
      "text": "Ask the questions the GPSR uses for a substantial modification: was the change foreseen in the initial risk assessment, has the nature of the hazard changed, has a new hazard appeared, has the level of risk increased? A change that answers no to all of them still needs a short written reasoning in the file.",
      "item": "product-validation"
    },
    {
      "name": "Re-test where a change touches a requirement",
      "text": "For each requirement the change affects, decide whether the existing test evidence still covers the product. Check at the same time whether the harmonised standards you declared against have been revised; the Low Voltage, EMC and Radio Equipment Directives require changes in those standards to be taken into account in the same way as changes in design."
    },
    {
      "name": "Update the technical documentation and the declaration",
      "text": "Bring the technical documentation up to date and revise the EU declaration of conformity where the identification, the standards or the applicable acts change. Under the Radio Equipment Directive both are continuously updated, and they are kept for 10 years after the equipment is placed on the market.",
      "item": "documentation-generator"
    },
    {
      "name": "Settle who is the manufacturer after a modification",
      "text": "If anyone other than the manufacturer, such as an importer, distributor or refurbisher, modifies the product substantially, that person becomes the manufacturer for the affected part or, where safety is affected, for the whole product. The GPSR does not require a written agreement, but a record of who carries out and documents changes shows where the duty lies."
    }
  ],
  "documents": [
    {
      "name": "A change record per product: what changed, from which serial or batch, and the impact assessment",
      "from": "The manufacturer, kept with the technical documentation",
      "ground": "GPSR Article 9(2)–(4); Directive 2014/35/EU Article 6(4); Directive 2014/30/EU Article 7(4); Directive 2014/53/EU Article 10(5)"
    },
    {
      "name": "The updated technical documentation and EU declaration of conformity",
      "from": "The manufacturer",
      "ground": "Directive 2014/53/EU Articles 10(4), 18(2) and 21(2); GPSR Article 9(3)"
    }
  ],
  "risks": [
    {
      "title": "You may become the manufacturer without planning to",
      "text": "A person other than the manufacturer that substantially modifies a product is deemed a manufacturer and takes on the manufacturer's obligations for the affected part, or for the whole product if safety is affected (GPSR Article 13(2) and (3)).",
      "source": 1
    },
    {
      "title": "Outdated documentation can trigger a paid test",
      "text": "Where the technical documentation fails to present sufficient data on the means used to ensure compliance, the market surveillance authority may ask the manufacturer or importer to have a test performed by an acceptable body at their own expense (Directive 2014/53/EU Article 21(4)).",
      "source": 4
    },
    {
      "title": "A non-conforming change must be corrected",
      "text": "Manufacturers who consider or have reason to believe that equipment they placed on the market is not in conformity must immediately bring it into conformity, withdraw it or recall it, as appropriate (Directive 2014/53/EU Article 10(11)); under the GPSR a dangerous product triggers corrective measures and a notification through the Safety Business Gateway (Article 9(8)).",
      "source": 4
    }
  ],
  "faq": [
    {
      "q": "Does a firmware or software update count as a change?",
      "a": "Yes, it can. The GPSR deems a modification substantial when it is made by physical or digital means, affects safety, was not foreseen in the initial risk assessment and changes or increases the hazard (Article 13(3)). From 20 January 2027 the Machinery Regulation also defines a substantial modification as one made by physical or digital means, with its own criteria (Regulation (EU) 2023/1230 Articles 3(16) and 54, dates as corrected by the corrigendum of 4 July 2023)."
    },
    {
      "q": "Do we need a new test report for every change?",
      "a": "The acts read for this page do not say so. They require changes in design or characteristics to be adequately taken into account (Directive 2014/35/EU Article 6(4)). Your impact assessment decides which requirements need new evidence, and the reasoning belongs in the technical documentation."
    },
    {
      "q": "We only switched to a new supplier for the same component. Does that matter?",
      "a": "It can. Manufacturers must keep procedures so that series production stays in conformity (GPSR Article 9(4); Directive 2014/30/EU Article 7(4)). A new supplier is a change in characteristics until you have shown that the part performs the same in the product."
    },
    {
      "q": "A harmonised standard we used was revised. Is that a change?",
      "a": "The Low Voltage, EMC and Radio Equipment Directives require changes in the harmonised standards by reference to which conformity is declared to be adequately taken into account (Directive 2014/35/EU Article 6(4); Directive 2014/30/EU Article 7(4); Directive 2014/53/EU Article 10(5))."
    },
    {
      "q": "A retailer wants to modify our product. Who is responsible?",
      "a": "If the modification is substantial, the retailer is deemed the manufacturer for the affected part, or for the whole product if the change affects its safety (GPSR Article 13(2)). Modifications made by consumers for their own use do not count (Article 13(3)(c))."
    }
  ],
  "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": "Directive 2014/30/EU on electromagnetic compatibility (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0030-20260530",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2014/53/EU on radio equipment (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0053-20260530",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2023/1230 on machinery (consolidated text of 27 July 2026, including the corrigendum of 4 July 2023)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1230-20260727",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "connected-product-radio",
    "emc-test-failed",
    "needs-ce-marking",
    "machinery-or-tool",
    "which-regulations-apply"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}