GPSR technical documentation: what to write

GPSR technical documentation is a file on your own shelf. The manufacturerArt. 3(8)any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademarkClick the term for the full definition writes it before the product is placed on the marketArt. 3(7)the first making available of a product on the Union marketClick the term for the full definition, and produces it when a market surveillance authority asks (Art. 9(3)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 3Click opens the article on EUR-Lex.).

The guidelines, section 3.1.1: “Below you can find a model template that may help you in the drafting and organisation of your technical documentation. This model template is not compulsory.” “You have to describe separately every potential risk identified and the measures that you have taken to mitigate or eliminate this risk”. “The technical documentation is to be prepared with respect to each product (product model), not individual units thereof.”

The page on whether GPSR applies to you settles whether GPSR reaches the product at all, and the Regulation itself is in the GPSR guide.

The duty is the manufacturerArt. 3(8)any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademarkClick the term for the full definition’s, and it lands at placing on the marketArt. 3(7)the first making available of a product on the Union marketClick the term for the full definition — the first making available of the product on the Union market (Art. 3(7)Regulation (EU) 2023/988, General Product Safety RegulationArticle 3, point 7Click opens the article on EUR-Lex.).

Two ways it becomes yours without you making anything. A person who places a product on the market under their own name or trademark is deemed to be the manufacturer and takes on the whole of Article 9Regulation (EU) 2023/988, General Product Safety RegulationArticle 9Click opens the article on EUR-Lex. (Art. 13(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 13, paragraph 1Click opens the article on EUR-Lex.). So is anyone who substantially modifies a product, for the affected part, or for the whole product where the modification affects its safety (Art. 13(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 13, paragraph 2Click opens the article on EUR-Lex.).

What goes in it, in the Regulation’s own words

The Regulation sets a floor, then a conditional layer on top of it.

Always. The documentation contains “at least a general description of the product and its essential characteristics relevant for assessing its safety” (Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex., first subparagraph). That is the minimum for every product, whatever its risk.

Where appropriate with regard to possible risks related to the product, the documentation shall also contain, as applicable (Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex., second subparagraph):

• (a) an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, “including the outcome of any reports related to tests conducted by the manufacturer or by another party on their behalf” (Art. 9(2)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2, point (a)Click opens the article on EUR-Lex.);
• (b) the list of any relevant European standards as referred to in Art. 7(1)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 1, point (a)Click opens the article on EUR-Lex., or the other elements referred to in Art. 7(1)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 1, point (b)Click opens the article on EUR-Lex. or Art. 8Regulation (EU) 2023/988, General Product Safety RegulationArticle 8Click opens the article on EUR-Lex., applied to meet the general safety requirement (Art. 9(2)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2, point (b)Click opens the article on EUR-Lex.).

Partial application is allowed, and it has to be visible. Where any of those European standards, health and safety requirements or elements have been only partly applied, the manufacturer identifies the parts which have been applied (Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex., third subparagraph).

Two words carry the weight: appropriate and applicable. A low-risk product does not get the same file as a product that heats up or bears a child’s weight. What the Regulation does not give you is a page count, a template, or a way to leave the general description out.

The condition is “where appropriate with regard to possible risks”. Write point (a) whenever the product can injure someone in a way the standards you applied do not already cover: anything that heats, cuts or bears weight, anything small enough for a child to swallow. A product with a plug or a battery is not in this file at all: electrical and electronic equipment falls under EU product laws of its own, and Art. 9Regulation (EU) 2023/988, General Product Safety RegulationArticle 9Click opens the article on EUR-Lex. does not apply to it (Art. 2(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex.; C/2025/6233, footnote 17). A simple product whose whole risk picture is covered by a published European standard you applied in full can rest on the list in point (b). The genuine edge case is a familiar product with an unfamiliar part, where the standard covers the product and not the part. There, write the analysis for the part.

What the risk analysis assesses

Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex. tells you to analyse the risks. Art. 6Regulation (EU) 2023/988, General Product Safety RegulationArticle 6Click opens the article on EUR-Lex. tells you what “safe” is measured against, and Art. 5Regulation (EU) 2023/988, General Product Safety RegulationArticle 5Click opens the article on EUR-Lex. is the general safety requirement the whole file exists to evidence. These aspects in particular shall be taken into account when assessing whether a product is a safe product (Art. 6(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1Click opens the article on EUR-Lex.):

• the characteristics of the product — design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance (Art. 6(1)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (a)Click opens the article on EUR-Lex.);
• its effect on other products it is reasonably foreseeable it will be used with, including interconnection (Art. 6(1)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (b)Click opens the article on EUR-Lex.);
• the effect other products might have on it, including non-embedded items meant to determine, change or complete how it works (Art. 6(1)(c)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (c)Click opens the article on EUR-Lex.);
• the presentation of the product, the labelling — including labelling on age suitability for children — any warnings and instructions for safe use and disposal (Art. 6(1)(d)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (d)Click opens the article on EUR-Lex.);
• the categories of consumers using it, in particular the risk for vulnerable consumers such as children, older people and persons with disabilities, and the impact of gender differences on health and safety (Art. 6(1)(e)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (e)Click opens the article on EUR-Lex.);
• the appearance of the product where it is likely to lead consumers to use it differently than designed: in particular a product that resembles foodstuff and might be placed in the mouth, sucked or ingested, especially by children, and a product not intended for children that is likely to be used by them or resembles an object commonly recognised as appealing to them (Art. 6(1)(f)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (f)Click opens the article on EUR-Lex.);
• when required by the nature of the product, appropriate cybersecurity features protecting it against external influences, including malicious third parties, where such influence might affect safety, including possible loss of interconnection (Art. 6(1)(g)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (g)Click opens the article on EUR-Lex.);
• when required by the nature of the product, its evolving, learning and predictive functionalities (Art. 6(1)(h)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 1, point (h)Click opens the article on EUR-Lex.).

One sentence of that Article stops a perfectionist reading of your own file. The feasibility of obtaining higher levels of safety, or the availability of other products presenting a lesser degree of risk, “shall not constitute grounds for considering a product to be a dangerous product” (Art. 6(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 6, paragraph 2Click opens the article on EUR-Lex.). The question is whether your product is safe, not whether a safer one could be imagined.

Those criteria bind national authorities, not you; GPSR does not make you use them. They build on the earlier RAPEX guidelines of Implementing Decision (EU) 2019/417 (recital of Delegated Regulation (EU) 2024/3173), and that Decision gives a worked example: a hammer head breaks (1/10), a piece hits the user (1/10), it hits the head (1/3), it hits the eye (1/20). “1/10 × 1/10 × 1/3 × 1/20 = 1/6 000. This translates into > 1/10 000”. On the grid in Delegated Regulation (EU) 2024/3173, “> 1/10 000” reads low, medium, high or serious risk as the severity rises from 1 to 4.

How the presumption from standards shortens the file

This is where the file gets shorter, legitimately.

A product is presumed to be in conformity with the general safety requirement where it conforms to relevant European standards, or parts of them, as far as the risks and risk categories covered by those standards are concerned, and the references of those standards have been published in the Official Journal of the European Union (harmonised standards are the same idea under the CE laws) (Art. 7(1)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 1, point (a)Click opens the article on EUR-Lex.).

For GPSR those references sit in one act: Commission Implementing Decision (EU) 2026/901 of 17 April 2026. Its Annex I lists 76 standard references, for example EN 716-1 for cots, EN 913 for gymnastic equipment and EN 14988 for high chairs. Its Annex II lists 4 older standards, which keep the presumption until 27 October 2027.

Where there is no such European standard, the presumption attaches to the health and safety requirements laid down in the national law of the EU country where the product is made available, as regards the risks those requirements cover, provided that law complies with Union law (Art. 7(1)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 1, point (b)Click opens the article on EUR-Lex.).

That is why Art. 9(2)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2, point (b)Click opens the article on EUR-Lex. asks for the list of what you applied. The list is how the presumption is claimed, and it is the shortest honest GPSR file there is: a standard’s reference number, the risks it covers, and — if you applied it only in part — which parts.

The Decision is published under Art. 10(7) of Regulation (EU) No 1025/2012 and repeals Implementing Decision (EU) 2019/1698. Its Article 1: “The references to European standards for products drafted in support of Regulation (EU) 2023/988Regulation (EU) 2023/988, General Product Safety RegulationThe whole regulationClick opens the law on the EU Publications Office., listed in Annex I to this Decision, are hereby published in the Official Journal of the European Union.”

The presumption has a hard edge. It does not stop market surveillance authorities from taking all appropriate measures under the Regulation where there is evidence that, despite the presumption, the product is dangerous (Art. 7(3)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 3Click opens the article on EUR-Lex.).

Where the presumption does not apply, these shall in particular be taken into account when available (Art. 8Regulation (EU) 2023/988, General Product Safety RegulationArticle 8Click opens the article on EUR-Lex.): European standards other than those published in the Official Journal (Art. 8(1)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 8, paragraph 1, point (a)Click opens the article on EUR-Lex.); international standards (b); international agreements (c); voluntary certification schemes or similar third-party conformity assessment frameworks, in particular those conceived to support Union law (d); Commission recommendations or guidelines on product safety assessment (e); national standards of the EU country where the product is made available (f); the state of the art and technology, including the opinion of recognised scientific bodies and expert committees (g); product safety codes of good practice in force in the sector (h); reasonable consumer expectations concerning safety (i); and safety requirements adopted under Art. 7(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 2Click opens the article on EUR-Lex. (j). Those are the elements Art. 9(2)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2, point (b)Click opens the article on EUR-Lex. means by “the other elements”.

No safety requirements had been adopted under Art. 7(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 2Click opens the article on EUR-Lex. as of 5 October 2026. The latest such act, Decision (EU) 2023/1338 of 28 June 2023 on children’s products, was adopted under the old Directive 2001/95/EC.

How long the file is kept, and by whom

The ten years are counted from the product, not from the company: the last unit you place starts its own ten years.

Who may hold the Art. 16Regulation (EU) 2023/988, General Product Safety RegulationArticle 16Click opens the article on EUR-Lex. role is the EU Responsible Person.

The two clocks in that last row are the ones that trip people: ten years for the risk and corrective-measure information, six for who supplied you and who you supplied. Storing the whole lot for ten is simpler than remembering which is which.

What traceability asks for, and what goes on the product itself

Traceability under GPSR is two ordinary things.

A purchase and sales record. On request from a market surveillance authority you identify and communicate any economic operatorArt. 3(13)the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market ...Click the term for the full definition who supplied you with the product — or with a part, a component or any software embedded in it — and any economic operator you supplied it to, for six years (Art. 15(3)Regulation (EU) 2023/988, General Product Safety RegulationArticle 15, paragraph 3Click opens the article on EUR-Lex., Art. 15(5)Regulation (EU) 2023/988, General Product Safety RegulationArticle 15, paragraph 5Click opens the article on EUR-Lex.). That is a record tied to a product identifier, not a system.

A product that can be identified. A type, batch or serial number or other element enabling identification, easily visible and legible for consumers, or on the packaging or an accompanying document where the product’s size or nature does not allow it (Art. 9(5)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 5Click opens the article on EUR-Lex.). With it: the manufacturer’s name, registered trade name or trade mark and postal and electronic address (Art. 9(6)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 6Click opens the article on EUR-Lex.), and clear instructions and safety information in a language easily understood by consumers, as determined by the EU country where the product is made available, unless the product can be used safely without them (Art. 9(7)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 7Click opens the article on EUR-Lex.). Those marking and instruction duties are a theme of their own, built on Art. 9(5)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 5Click opens the article on EUR-Lex., (6) and (7) above: marking is on GPSR labelling requirements, instructions on EU user manual requirements.

Beyond that, the Commission may set up a dedicated traceability system for certain products, categories or groups of products likely to present a serious risk, by delegated act, specifying the data to collect and store and how it is displayed and accessed, including a data carrier on the product, its packaging or accompanying documents (Art. 18(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 18, paragraph 1Click opens the article on EUR-Lex., Art. 18(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 18, paragraph 2Click opens the article on EUR-Lex., Art. 18(3)Regulation (EU) 2023/988, General Product Safety RegulationArticle 18, paragraph 3Click opens the article on EUR-Lex.). No such delegated act had been adopted as of 5 October 2026. Until one names your product, Art. 15Regulation (EU) 2023/988, General Product Safety RegulationArticle 15Click opens the article on EUR-Lex. is your traceability obligation.

What happens if you do not write it

The first consequence is not a fine. It is a request you cannot answer.

An economic operator shall, on request by a market surveillance authority, provide all necessary information, in particular a full description of the risk presented by the product, related complaints and known accidents, and a description of any corrective measure taken (Art. 15(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 15, paragraph 2Click opens the article on EUR-Lex.). Authorities may also require regular progress reports and decide whether or when a corrective measure can be considered completed (Art. 15(6)Regulation (EU) 2023/988, General Product Safety RegulationArticle 15, paragraph 6Click opens the article on EUR-Lex.). A manufacturer who never ran the internal risk analysis has nothing to send.

The second arrives through your own supply chain, and it arrives sooner. An importer must not place the product on the market where it considers or has reason to believe that the product is not in conformity with Art. 5Regulation (EU) 2023/988, General Product Safety RegulationArticle 5Click opens the article on EUR-Lex. and Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex., (5) and (6), until it has been brought into conformity (Art. 11(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 11, paragraph 2Click opens the article on EUR-Lex.). A responsible person asked for documented evidence that the product complies with the technical documentation, and finding there is none, has a problem it must act on (Art. 16(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 16, paragraph 2Click opens the article on EUR-Lex.). Your customers stop before an authority does.

The third is national. GPSR sets no figure itself: each EU country lays down the rules on penalties for infringements and takes the measures necessary to ensure they are implemented, and the Regulation asks only that they be effective, proportionate and dissuasive (Art. 44Regulation (EU) 2023/988, General Product Safety RegulationArticle 44Click opens the article on EUR-Lex.). What each country actually sets is listed in GPSR fines.

What you can skip

How to write it yourself

The Regulation puts the internal risk analysis and the drawing up of the documentation on the manufacturer (Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex.). It names no consultant, no laboratory and no service.

For a low-risk product with a European standard behind it, the honest file is short: what the product is, its essential characteristics relevant to safety, the standard’s reference and which parts of it you applied, and the risks you looked at with what you did about them. You can write that yourself, and it is a complete answer to Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex.. No vendor is needed for it.

Paid help earns its money in two narrow places: a test you cannot physically run, and a product whose hazards you do not understand well enough to analyse. Neither is a legal requirement, and both are decisions about the product, not about the paperwork. Economic operators must in any case have internal processes for product safety in place (Art. 14Regulation (EU) 2023/988, General Product Safety RegulationArticle 14Click opens the article on EUR-Lex.). That part cannot be bought in.

What the law leaves open

• The language of the technical documentation. Articles 9Regulation (EU) 2023/988, General Product Safety RegulationArticle 9Click opens the article on EUR-Lex. and 15Regulation (EU) 2023/988, General Product Safety RegulationArticle 15Click opens the article on EUR-Lex. set no language rule for the file itself. Art. 9(7)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 7Click opens the article on EUR-Lex. sets one for instructions and safety information to consumers, and Art. 10(2)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 10, paragraph 2, point (a)Click opens the article on EUR-Lex. obliges an authorised representative to supply documentation in an official language the requesting authority understands. Meanwhile, keep the file in a language you can work in, and be ready to hand it over in an official language of the country whose authority asks.