CE technical file: what it holds, who keeps it, for how long

The technical file is the manufacturer’s folder of evidence that a product meets the EU law that covers it. Most EU product laws call it “technical documentation”. The Machinery Directive calls it the “technical file”. It is one thing under two names, and this page uses both.

You write it before the product goes on sale in the EU, you keep it, and you produce it when an authority asks. Under internal production control it is not filed anywhere; where your law brings in a notified body, the file goes to that body with the application.

What you do:

1. Find the EU law that covers your product. A technical file belongs to a product under an EU law that provides for CE marking: toys, electrical equipment, electronic apparatus, radio equipment, machinery and the others listed in CE marking. If no EU product law covers the product, the file you need is the GPSR one, on GPSR technical documentation (Art. 2(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex., point (b), takes Chapter III Section 1, which holds Art. 9Regulation (EU) 2023/988, General Product Safety RegulationArticle 9Click opens the article on EUR-Lex., off a product under Union harmonisation legislation).
2. Settle whether you are the manufacturer. You are if you make the product, or have it made, and sell it under your own name or brand (Art. 2(3)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 2, paragraph 3Click opens the article on EUR-Lex., Art. 10Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 10Click opens the article on EUR-Lex.). Then the file is yours. Under most laws an authorised representative cannot draw it up for you (Art. 7(1)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 7, paragraph 1Click opens the article on EUR-Lex.).
3. Write the file from your law’s list. The model’s list is eight items (the checklist below). Each law then adds to it or changes it (the table after it).
4. Finish it before the product is placed on the market, and keep it true. Update it when the design or the standards you rely on change, and keep production matching it (Decision No 768/2008/EC, Annex I, Art. R2(4); Annex II, Module A, point 3).
5. Keep it for 10 years after the product is placed on the market. Machinery and medical devices count differently, and the sections below say how (Art. 6(3)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 6, paragraph 3Click opens the article on EUR-Lex.).
6. If you import the product, make sure the manufacturer drew the file up and that it can be produced when an authority asks (Art. 8(2)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 8, paragraph 2Click opens the article on EUR-Lex., Art. 8(8)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 8, paragraph 8Click opens the article on EUR-Lex.). You do not have to hold a copy yourself (Blue Guide, section 3.3, footnote 143).
7. If you sell from outside the EU a product under a law listed in Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020 (toys, RoHS, low voltage, EMC, radio, the Machinery Directive and others), an EU-based operator must verify that the file exists and can make it available. An EU importer fills that role without being named separately. Without an importer, you name an authorised representative with a written mandate. The operator’s name and postal address go on the product, its packaging, the parcel or a document that comes with it (Art. 4(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex., Art. 4(2)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 2Click opens the article on EUR-Lex., point (b), Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex., Art. 4(4)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 4Click opens the article on EUR-Lex.).
8. When an authority asks for the file with a reasoned request, send what answers the request, in a language the authority easily understands. The law asks for “all the information and documentation necessary to demonstrate the conformity” (Art. 6(9)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 6, paragraph 9Click opens the article on EUR-Lex.; Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex., point (b)). The Blue Guide says it is sufficient to provide the part of the technical documentation related to the claimed non-conformity (Blue Guide, section 7.4.1.1). The authority may still ask for more.

Each CE law points to its own list of what the file holds

Decision No 768/2008/EC is a model for EU product laws. A law builds on it unless it departs from it (Article 2 of Decision No 768/2008/EC), and the model’s internal production control procedure, Module A, sets what the technical documentation holds. Each law then names its own list, as below. A CE law that is not in the table follows the same pattern unless it departs from it.

The model’s checklist has eight items, from a description to the applicable requirements

This is the list in Module A of the model. The Low Voltage Directive repeats it in Annex III, point 2, and the EMC Directive in Annex II, point 3. Other laws build on it or replace it, as the next table shows. The documentation “shall, wherever applicable, contain at least” these elements, so the list is a floor. Where an item does not apply to your product, leave it out. Where your product needs more to show conformity, add it.

What each law adds to the eight items, or changes

One product under several laws still needs every law’s items in its file

A product can fall under several of these laws at once. The model tells lawmakers to provide for a single EU declaration of conformity that covers every act that applies to the product (Decision No 768/2008/EC, Art. 5). For the technical documentation, RoHS says the same in terms: where another law requires a conformity assessment procedure at least as stringent, “A single technical documentation may be drawn up” (Art. 7(c)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (c)Click opens the article on EUR-Lex.). The other laws read for this page give each law its own list and do not say how to arrange them. One folder with a section for each law that applies, and a cross-reference where an item serves two, keeps every list in view.

The manufacturer writes the file; an authorised representative usually cannot

In the laws built on the model, the mandate of an authorised representative leaves out the drawing-up of the technical documentation (Art. 7(1)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 7, paragraph 1Click opens the article on EUR-Lex., Art. 8(1)Directive 2014/30/EU, Electromagnetic Compatibility Directive (consolidated text of 30 May 2026)Article 8, paragraph 1Click opens the article on EUR-Lex., Art. 11(1)Directive 2014/53/EU, Radio Equipment Directive (consolidated text of 30 May 2026)Article 11, paragraph 1Click opens the article on EUR-Lex., Art. 5(2)Directive 2009/48/EC, Toy Safety DirectiveArticle 5, paragraph 2Click opens the article on EUR-Lex., Art. 8Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 8Click opens the article on EUR-Lex., point (a), Art. 12(1)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 12, paragraph 1Click opens the article on EUR-Lex.). The Commission’s Blue Guide (section 3.2) says the manufacturer may delegate neither the production measures nor “the drawing up of technical documentation, unless otherwise provided for”. The Machinery Directive is such an exception: the manufacturer “or his authorised representative” ensures the technical file is available (Art. 5(1)Directive 2006/42/EC, Machinery Directive (consolidated text of 30 May 2026)Article 5, paragraph 1Click opens the article on EUR-Lex., point (b)), and the declaration names a person in the EU who is authorised to compile it.

An importer is not obliged to hold a copy, but must ensure that the file can be produced. Under the GPSR the rule is stricter: the importer keeps its own copy of the technical documentation for 10 years (Art. 11(6)Regulation (EU) 2023/988, General Product Safety RegulationArticle 11, paragraph 6Click opens the article on EUR-Lex.). The Blue Guide advises it to “require formal assurance in writing from the manufacturer that the documents will be made available” (section 3.3, footnote 143). A distributor is “not expected to be in possession of the relevant documentation” (section 3.4).

Your brand on the factory’s product makes the factory’s file your responsibility

A product sold under your name makes you the manufacturer for EU law, whoever built it. The factory does not take the duty from you (Art. 2(3)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 2, paragraph 3Click opens the article on EUR-Lex., Art. 10Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 10Click opens the article on EUR-Lex.). Its certificate, test reports and drawings are evidence you may use, but you must hold the documentation yourself, and it must show that your specific product complies. A factory file written under the factory’s own name can serve you if it does. It does not need to carry your name.

Keep the file 10 years after each product is placed on the market, and keep it true

Most laws set 10 years from the time 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. A few count differently, and one adds a longer floor.

Each unit starts its own clock. The Blue Guide (section 4.3) says the period “needs to be calculated from the moment when the individual product that is covered by the technical documentation is placed on the market”, and its footnote 115 reads the manufacturer’s 10 years as running from “the last item of the product model placed on the market”. Keep the file for a model until that date.

A file is not written once. Changes in the product’s design or characteristics, and changes in the standards or specifications it is declared against, must be “adequately taken into account” (Decision No 768/2008/EC, Annex I, Art. R2(4)), and production has to keep matching the file (Annex II, Module A, point 3). Radio equipment’s file must be “continuously updated” (Art. 21(2)Directive 2014/53/EU, Radio Equipment Directive (consolidated text of 30 May 2026)Article 21, paragraph 2Click opens the article on EUR-Lex.).

An authority can ask for the file, and you answer in a language it understands

A market surveillance authority can require an economic operator to provide “relevant documents, technical specifications, data or information on compliance and technical aspects of the product” (Art. 14(4)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 14, paragraph 4Click opens the article on EUR-Lex., point (a)). Each CE law then fixes the duty from the other side. On a reasoned request the manufacturer gives the authority “all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority” (Decision No 768/2008/EC, Annex I, Art. R2(9); Art. 6(9)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 6, paragraph 9Click opens the article on EUR-Lex.). The importer and the EU-based operator carry the same duty (Art. 8(9)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 8, paragraph 9Click opens the article on EUR-Lex., Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex., point (b)).

What the authority can and cannot ask, in the Blue Guide’s words (section 7.4.1.1):

• The authority “cannot request it systematically”. It can ask for it “during checks made for market surveillance purposes, or when there are grounds for concern that a product does not offer the level of protection required”.
• “The full technical documentation should be requested only where clearly necessary”. On a reasoned request, “it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity”.
• A request for translation “should be limited to these parts of the documentation”. “No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities”. The authority may accept a language it understands that is not its national language, “a third language, if accepted by that authority”.
• The file may be kept and sent “in paper or electronic form”. Everyone who receives information about its contents during market surveillance is bound to confidentiality under national law.

If the file is missing or incomplete, the authority orders you to fix it first

Where an authority finds that the technical documentation is “either not available or not complete”, it requires the operator to end the non-compliance. If that persists, it takes all appropriate measures to restrict or prohibit the product being made available, or to have it recalled or withdrawn (Art. 22(1)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 22, paragraph 1Click opens the article on EUR-Lex., point (e), Art. 22(2)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 22, paragraph 2Click opens the article on EUR-Lex.; the same rule is in Art. 40Directive 2014/30/EU, Electromagnetic Compatibility Directive (consolidated text of 30 May 2026)Article 40Click opens the article on EUR-Lex., Art. 43Directive 2014/53/EU, Radio Equipment Directive (consolidated text of 30 May 2026)Article 43Click opens the article on EUR-Lex., Art. 45Directive 2009/48/EC, Toy Safety DirectiveArticle 45Click opens the article on EUR-Lex. and Art. 46Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 46Click opens the article on EUR-Lex.). The Blue Guide (section 7.4.1.1) adds that failure to present the documentation “in response to a reasoned request by a national market surveillance authority, within an acceptable timeframe, is a non-compliance and may constitute sufficient grounds for doubting the conformity of the product”. The Machinery Directive says the same of the machinery file (Annex VII, part A, point 3).

Your own supply chain stops before an authority does. An importer must not place a product on the market where it considers or has reason to believe that the product does not conform, until it has been brought into conformity (Art. 8(2)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 8, paragraph 2Click opens the article on EUR-Lex.).

A seller outside the EU needs an EU operator who can produce the file

A product under one of the laws listed in Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office., which include the toy, RoHS, low-voltage, EMC, radio and machinery (Directive 2006/42/ECDirective 2006/42/EC, Machinery Directive (consolidated text of 30 May 2026)The whole regulationClick opens the law on the EU Publications Office.) laws, may be placed on the market only if an 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 established in the EU is responsible for the tasks in Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex. (Art. 4(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex., Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex.). That operator is one of four (Art. 4(2)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 2Click opens the article on EUR-Lex.):

• an EU-based manufacturer;
• an importer, where the manufacturer is not in the EU;
• an authorised representative with a written mandate from the manufacturer; or
• an EU-based fulfilment service provider, for the products it handles, where none of the other three exists.

Its tasks include verifying that the technical documentation has been drawn up and ensuring it can be made available to the authorities on request, and giving the authority what it asks for in a language it easily understands (Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex., points (a) and (b)). Its name and postal address go on the product, its packaging, the parcel or an accompanying document (Art. 4(4)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 4Click opens the article on EUR-Lex.). An online offer counts as a product made available in the EU when it is targeted at end users there (Art. 6Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 6Click opens the article on EUR-Lex.).

This operator verifies the file. It does not write it. As a non-EU manufacturer you still draw the file up, unless your law says otherwise, as the Machinery Directive does. Where the EU operator does not keep the file itself, the Blue Guide (section 3.6) says it must check “that the documentation exists” and obtain “assurances from the manufacturer that it will share it on request”. Who can hold the role, and what it costs, is on the EU Responsible Person; how it differs from an authorised representative is on EU authorised representative.

The machinery file has its own name, its own clock and its own old rules

The Machinery Directive’s own name for the file is the “technical file”. Before placing machinery on the market, the manufacturer or its authorised representative must “ensure that the technical file referred to in Annex VII, part A is available” (Art. 5(1)Directive 2006/42/EC, Machinery Directive (consolidated text of 30 May 2026)Article 5, paragraph 1Click opens the article on EUR-Lex., point (b)). The declaration of conformity names “the person authorised to compile the technical file, who must be established in the Community” (Annex II, part 1, section A, point 2). For this law the 10 years run from the date of manufacture, or from the last unit of a series, not from placing on the market (Annex VII, part A, point 2). Read the table above for what the file holds.

The search “technical construction file” lands here. Recital 24 of the Machinery Directive says the manufacturer “should prepare a technical construction file”. The operative text says “technical file”, and its first part is “a construction file”. Of the texts read for this page, only that recital uses “technical construction file”. The Low Voltage, EMC, Radio Equipment, Toy Safety and Machinery Regulation texts call the manufacturer’s file “technical documentation”.

From 20 January 2027 the Machinery Regulation replaces the Directive. Its file is “technical documentation” under Annex IV, part A; the manufacturer keeps it at least 10 years after the machinery is placed on the market or put into service, and must give the authorities the source code or programming logic of safety-related software on a reasoned request, where that is necessary to check compliance (Art. 10(2)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 10, paragraph 2Click opens the article on EUR-Lex., Art. 10(3)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 10, paragraph 3Click opens the article on EUR-Lex., Art. 54Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 54Click opens the article on EUR-Lex.). The Directive stays in force until then (Art. 51(2)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 51, paragraph 2Click opens the article on EUR-Lex.). Both texts are covered on machinery directive.

Medical devices keep the file at least 10 years, and 15 for implantable devices

The manufacturer of a medical device keeps the technical documentation, the declaration of conformity and any certificate available to the authorities for at least 10 years after the last device covered by the declaration is placed on the market, and for at least 15 years for implantable devices. On request the manufacturer provides the technical documentation “in its entirety or a summary thereof” (Art. 10(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 4Click opens the article on EUR-Lex., Art. 10(8)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 8Click opens the article on EUR-Lex.). The rest of the regime is on EU MDR.

Great Britain asks for a technical file too

The UK government’s guidance says: “Under UKCA and CE regulations, manufacturers must prepare a technical file”. In most cases it can be digital and should include test reports, design documents, risk assessments and the other information that the regulation for the product lists. The documentation is kept for the period set in the legislation, “typically 10 years”, counted from “each individual product” placed on the Great Britain market, “rather than the first product of a production run” (UK government, updated 21 August 2026). What Great Britain accepts as a CE or UKCA marking is on CE marking.

What the technical file is not

• It is not filed or registered. It is kept “at the disposal of the national authorities” (Decision No 768/2008/EC, Annex II, Module A, point 4.2) and produced on a reasoned request. Under internal production control nothing is sent anywhere in advance. Where your law brings in a notified body, the file goes to that body with the application (Decision No 768/2008/EC, Annex II, Module B, point 3; Art. 21Directive 2014/53/EU, Radio Equipment Directive (consolidated text of 30 May 2026)Article 21Click opens the article on EUR-Lex. and Annex III, point 3(c), of the Radio Equipment Directive).
• It is not published. The Blue Guide (section 7.4.1.1) says that everyone who receives information about its contents during market surveillance is bound to confidentiality under national law.
• It is not the declaration of conformity. The declaration is a separate document kept with the file (Annex II, Module A, point 4.2). A copy of it is one item inside the file under the Radio Equipment, Toy Safety and Machinery Directives (Annex V of the Radio Equipment Directive, Annex IV of the Toy Safety Directive, Annex VII of the Machinery Directive). What goes into the declaration is on declaration of conformity.
• It is not a certificate. No body issues it. A notified body’s certificate is at most one item in it, where a notified body took part (Annex V of the Radio Equipment Directive, Annex IV of the Toy Safety Directive); what the body does is on notified body.
• It is not a test report. A test report is one of its items. Toy test reports go in the toy file (Annex IV of the Toy Safety Directive, point (g)), and the toy test standards are on EN 71.
• It has no prescribed form. The laws read for this page set contents, not a template or a file format; low-voltage Art. 6(9)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 6, paragraph 9Click opens the article on EUR-Lex. names “paper or electronic form”.