--- title: "We have sold for years without technical documentation" description: "Since 13 December 2024 the General Product Safety Regulation requires an internal risk analysis and technical documentation before a product is placed on the market. Products under CE directives have long needed a technical file. Products placed before that date under the old directive may still be sold, but every new unit needs the file. Inventory the range, rebuild the files by risk, and test where evidence is missing." type: "problem" url: "https://www.conphora.com/solutions/problem/no-technical-documentation/" markdown: "https://www.conphora.com/solutions/problem/no-technical-documentation.md" locale: "en" language: "en" updated: "2026-10-05" author: "Conphora compliance team" publisher: "Conphora" source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R0988-20260529" tags: ["GPSR", "LVD", "documentation"] license: "Free to quote with attribution and a link to the page" --- # We have sold for years without technical documentation Since 13 December 2024 the General Product Safety Regulation requires an internal risk analysis and technical documentation before a product is placed on the market. Products under CE directives have long needed a technical file. Products placed before that date under the old directive may still be sold, but every new unit needs the file. Inventory the range, rebuild the files by risk, and test where evidence is missing. ## Why this happens For many consumer products the duty to hold a technical file is recent. The General Product Safety Regulation (EU) 2023/988 applies from 13 December 2024 (Article 52) and repealed Directive 2001/95/EC from the same date (Article 50). Before placing products on the market, manufacturers now carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety (Article 9(2)). Products placed on the market before 13 December 2024 in conformity with the old directive may continue to be made available (Article 51), but that rule covers units already placed, not the next shipment, because placing on the market is the first making available of each product (Article 3(7)). [1] The required content scales with risk. Where appropriate with regard to the possible risks, the GPSR file contains an analysis of the risks and the solutions adopted to eliminate or mitigate them, including the outcome of test reports, and the list of European standards or other elements applied to meet the general safety requirement; where a standard was only partly applied, the parts applied are identified (Article 9(2)). The manufacturer keeps the file up to date, keeps it for 10 years after the product has been placed on the market and makes it available to authorities on request (Article 9(3)). For CE products the Commission's Blue Guide counts the 10 years from the last unit of the model placed on the market (footnote 115), and the same reading is the safe course for a GPSR file. [1] CE-marked products had a file duty already. For products under a product-specific harmonisation act (such as the CE directives), the GPSR's obligations of economic operators in Chapter III, Section 1 do not apply (Article 2(1), third subparagraph, point (b)); the act itself requires the file. [1] Under the Low Voltage Directive 2014/35/EU, for example, the manufacturer draws up the technical documentation in Annex III before drawing up the declaration and affixing the CE marking, and keeps it for 10 years (Article 6(2) and (3)). Annex III lists the general description, drawings, explanations, standards applied, design calculations, examinations and test reports, together with an adequate analysis and assessment of the risks. [2] Importers feel the gap first. Before placing a product on the market, an importer ensures that the manufacturer has drawn up the technical documentation, and an importer with reason to believe it is missing does not place the product on the market until the gap is closed (GPSR Article 11(1) and (2)). The importer then keeps a copy of the documentation for 10 years (Article 11(6)). [1] A missing file is enforceable even when the product itself is sound. Market surveillance authorities can require documents in any form (Regulation (EU) 2019/1020 Article 14(4)(a)), order the operator to rectify formal non-compliance, and, if nothing happens, ensure that the product is withdrawn or recalled (Article 16(3) and (5)). [3] ## How to solve it 1. **Inventory the range that is still being placed on the market** List every model still produced, imported or reordered, with its sales channels and countries. Mark which ones fall under a harmonisation act such as the Low Voltage Directive and which only under the GPSR. Models no longer placed on the market go to the end of the list. 2. **Rank the gaps by risk and exposure** Start with products used by children or other vulnerable consumers, products with known complaints, and products sold in high volumes or through marketplaces that ask for documents. A short list of files done well is worth more than many thin ones. 3. **Rebuild each file around the required minimum** For a GPSR product, write a general description and the characteristics relevant for safety, then the risk analysis with the solutions adopted, the test reports and the standards applied. For a CE product, follow the act's list, such as the Module A elements in Annex III of the Low Voltage Directive. 4. **Test where the evidence is missing** Old test reports may refer to another model, a withdrawn standard or a supplier's sample. Where the evidence does not match the product sold today, test it again before relying on it, and note which parts of a standard were applied. 5. **Set up the routine that keeps files current** Tie each file to series production: a change in design, components, standards or suppliers triggers a review. Keep the documentation up to date and available for 10 years after the last unit was placed on the market. ## What you need to show - **A range inventory with the act and file status per model** — The manufacturer or importer - **Technical documentation per model, with the internal risk analysis** — The manufacturer (GPSR Article 9(2); Directive 2014/35/EU Article 6(2) and Annex III) - **Current test reports matched to the model and the standard version** — A laboratory, commissioned by the manufacturer (GPSR Article 9(2)(a); Directive 2014/35/EU Annex III point 2(f)) ## If you do nothing - **Importers must stop until the file exists** — Before placing a product on the market, importers ensure that the manufacturer has drawn up the technical documentation; an importer with reason to believe this is not done must not place the product until it is brought into conformity (GPSR Article 11(1) and (2)). - **The authority asks and you have nothing to send** — Manufacturers make the documentation available to market surveillance authorities on request (GPSR Article 9(3)); authorities may require documents in any form and take copies (Regulation (EU) 2019/1020 Article 14(4)(a)). - **Formal non-compliance leads to corrective action** — Authorities require operators to rectify formal non-compliance, and where the operator fails to act they ensure withdrawal, recall or a prohibition (Regulation (EU) 2019/1020 Article 16(3)(a) and (5)). ## Questions ### Does the GPSR apply to products we already sold before December 2024? Member States may not impede the making available of products that conform to Directive 2001/95/EC and were placed on the market before 13 December 2024 (GPSR Article 51). The regulation applies from 13 December 2024 (Article 52), so products placed on the market from that date need the risk analysis and technical documentation. ### Our products carry CE marking. Do we need a GPSR file too? For products under a product-specific harmonisation act (such as the CE directives), the GPSR's Chapter III, Section 1 on economic operators' obligations does not apply (Article 2(1), third subparagraph, point (b)); the act's own technical file applies, and the GPSR's safety requirements cover only risks the act does not (point (a)). ### How detailed must a GPSR file be? At least a general description of the product and its essential characteristics relevant for safety. Where appropriate with regard to the risks, it also contains the risk analysis and solutions adopted, test report outcomes and the standards or other elements applied (GPSR Article 9(2)). ### Can we write the file now for a product made years ago? The documentation describes the product as it is placed on the market now and must be kept up to date (GPSR Article 9(3)). A file written today is valid if it is accurate for the units you are placing on the market; it cannot repair units that were already non-compliant. ### We only import. Is the file our job? The manufacturer draws it up (GPSR Article 9(2)). The importer checks that it exists before placing the product on the market and keeps a copy for 10 years (Article 11(1) and (6)). ## Regulations involved GPSR, LVD ## Sources 1. [Regulation (EU) 2023/988 on general product safety (consolidated text of 29 May 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R0988-20260529) — EUR-Lex, 2026-10-04 2. [Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits (consolidated text of 30 May 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0035-20260530) — EUR-Lex, 2026-10-04 3. [Regulation (EU) 2019/1020 on market surveillance and compliance of products (consolidated text of 12 August 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R1020-20260812) — EUR-Lex, 2026-10-04