Technical File for CE Marking: Content, Evidence, Retention
What a CE marking technical file must contain: product description, risk assessment, test reports, supplier evidence, 10-year retention and version control.

An EU declaration of conformity is the manufacturer's signed statement that a product meets all the EU laws that apply to it. Its content follows the model in Annex III of Decision No 768/2008/EC: product identification, manufacturer details, a sole responsibility statement, the laws and standards applied, any notified body involved, and a signature block. One single declaration covers all applicable laws.
The EU Declaration of Conformity (DoC) is the document in which the manufacturer declares that the product meets all the requirements of the EU laws that apply to it. By drawing it up, the manufacturer takes responsibility for that conformity. It is the last step before the CE marking is affixed.
The declaration is short, often one or two pages. It is signed by a person with the authority to commit the company. It is not a test report and it is not a certificate issued by a third party. It is your own legal statement, so treat the signature with the same care as a contract.
The declaration and the CE marking belong together. The declaration is the signed statement; the CE marking is its visible sign on the product. Construction products are an exception: under the Construction Products Regulation, the manufacturer issues a Declaration of Performance instead.
Most EU product laws follow the model declaration in Annex III of Decision No 768/2008/EC. The table below lists its items in order.
| Item | What to write |
|---|---|
| 1. Product model | A number that identifies the product model. Many manufacturers also give the declaration its own reference code. |
| 2. Manufacturer | Name and address of the manufacturer or of its authorised representative. |
| 3. Responsibility statement | "This declaration of conformity is issued under the sole responsibility of the manufacturer." |
| 4. Object of the declaration | Identification that allows traceability: model, type, batch or serial numbers and, where useful, an image. |
| 5. EU legislation | A statement that the object is in conformity with the relevant Union legislation, with the full reference of each law. |
| 6. Standards | References to the harmonised standards used, or other technical specifications, with their editions. |
| 7. Notified body | Where one was involved: its name and number, a short description of what it did and the certificate number. |
| 8. Additional information | Any additional information. |
| Signature block | "Signed for and on behalf of", place and date of issue, name and function of the signatory, signature. |
If you applied a harmonised standard only in part, the declaration should make clear which parts were applied. Listing a standard you applied only partly can mislead authorities and customers. Our guide to harmonised standards explains why the edition and the extent of application matter.
A clean layout helps customs officers and inspectors, who usually read the declaration quickly. A practical structure, from top to bottom:
The CE Marking Fundamentals course provides a declaration template built on Annex III, with placeholder fields, and a worked exercise. In that exercise, a fictitious Turkish manufacturer drafts the declaration for a bottle-labelling machine with a Wi-Fi module. The machine is placed on the market after 20 January 2027 and before 11 December 2027, with no notified body needed. The declaration lists Regulation (EU) 2023/1230 on machinery, Directive 2014/53/EU on radio equipment together with Delegated Regulation (EU) 2022/30, and Directive 2011/65/EU on RoHS. It does not list the Low Voltage Directive or the EMC Directive, because the machinery and radio laws already cover those aspects.
A few rules apply to every declaration:
Some laws require the declaration to travel with the product. Under the Radio Equipment Directive (RED), each unit comes with a copy of the declaration or a simplified declaration with an internet address. Your EU importer or authorised representative should also hold a copy of the current version. The declaration sits at the end of the technical file, and its content must match the file, the instructions and the nameplate.
Machinery has its own rules. Under the Machinery Directive, Directive 2006/42/EC, the declaration must accompany the machine, and its content is set out in Annex II. It includes one item not found in the general model: the name and address of the person authorised to compile the technical file, who must be established in the EU.
Regulation (EU) 2023/1230, which applies to machinery placed on the market from 20 January 2027, has its own content for the declaration. It allows more flexibility in how the declaration is provided: either a copy with the machine or, under conditions, an internet address where it can be found. Check the exact rules on content and format in the Regulation. Our guide to the Machinery Regulation 2023/1230 covers the wider changes.
Partly completed machinery is a special case. It is an assembly that cannot perform a specific application on its own, such as a robot arm sold for integration into a production line. It does not carry the CE marking under the machinery law. Instead, the manufacturer provides a declaration of incorporation and assembly instructions. The declaration of incorporation states which essential requirements have been applied and met, and that the assembly must not be put into service until the final machine has been declared in conformity. The Machinery Regulation keeps this approach.
These errors come up repeatedly in market surveillance checks and customs controls:
Each of these can turn a routine check into a long discussion. A short internal check before release, comparing the declaration with the plate and the file, avoids most of them.
Key points
CE Marking Fundamentals takes you from the EU market rules to your first shipment, with templates and quizzes. Module 1 is free.
No. When several EU laws apply and each requires a declaration, you draw up a single declaration that lists all of them. Each law is cited with its full reference.
A person with the authority to commit the manufacturer's company signs it, "for and on behalf of" the company, with place, date, name and function. The manufacturer's authorised representative can also appear as the issuer, but the declaration remains under the manufacturer's sole responsibility.
A declaration of conformity covers a finished product that bears the CE marking. A declaration of incorporation accompanies partly completed machinery, which does not bear the CE marking under the machinery law. It states which essential requirements were applied and that the assembly must not be put into service until the final machine is declared in conformity.
For 10 years, like the technical documentation, unless the specific law sets a different period. Keep superseded versions for the units they covered.
This guide is general training material, not legal advice. EU rules and standard citations change: check the latest texts in the Official Journal of the European Union before you decide.
What a CE marking technical file must contain: product description, risk assessment, test reports, supplier evidence, 10-year retention and version control.
Machinery Regulation 2023/1230 changes from 20 January 2027: per-unit transition, Annex I Part A and B, partly completed machinery and digital instructions.
Is there a CE certificate? Why module A products have none, what notified bodies issue, how voluntary certificates differ and what to give buyers instead.
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