What Is the CE Technical File?

One of the most frequently mentioned but least understood concepts in the CE marking process is the "technical file." Many manufacturers confuse it with a single PDF document, or with the CE certificate itself; in reality, the technical file is a living, comprehensive body of documentation that proves every engineering decision made from the product's design through to its manufacture. In this article we cover in detail what the technical file is, who is responsible for preparing it, which documents it needs to contain, and the obligations around keeping it.

The Concept and Purpose of the Technical File

The technical file (technical documentation) is the complete set of evidentiary documents showing how a product, at its design and manufacturing stages, meets the essential health and safety requirements defined in the relevant EU directives and regulations. A similar concept of the technical file appears across most CE legislation — most notably the Machinery Directive 2006/42/EC, but also the Low Voltage Directive and the Radio Equipment Directive — and although the content details vary by product group, the purpose is the same: to show that the conformity the manufacturer claims is not an arbitrary declaration, but rests on concrete engineering work.

The reason the technical file exists is that CE marking is based on a self-declaration system. For most product groups, EU legislation allows the manufacturer to issue a declaration of conformity under its own responsibility, without having it approved by an independent body. For this flexibility to remain reliable, the manufacturer is required to have a concrete set of technical grounds to stand behind — the technical file is exactly that set of grounds. When market surveillance authorities have doubts about a product, the technical file is the first document they will request.

Is the Technical File a CE Certificate?

No — and this distinction is one of the points we most often explain to our clients as a CE consultancy firm. The concept of a "CE certificate" is already a misnomer for most product groups, because for most of the legislation there is no "certificate" as such — instead there is the EU declaration of conformity, which the manufacturer signs itself. The technical file, meanwhile, is the internal documentation underlying that declaration; it is not a document approved by a third party, but an evidence file kept in the manufacturer's own archive. For high-risk product categories (for example, certain machine types listed in Annex IV of the Machinery Directive), a notified body may review this file, but even then the technical file itself does not become a certificate — it remains the source document underlying the review.

What Does the Technical File Contain?

Content varies by product type, but we can summarize the minimum elements using the example of Annex VII of the Machinery Directive. The table below shows the typical sections of a technical file and what is expected in each.

It's worth emphasizing that this list is not a fixed template — it can expand or contract depending on the product's complexity and risk profile. A relatively lean file may be sufficient for a simple power tool, while a complex production line with integrated safety circuits requires a much more extensive set of calculations and verification records.

Who Is Obligated to Prepare It?

The obligation to prepare and keep the technical file up to date rests primarily with the manufacturer. If the manufacturer is established outside the European Union, this responsibility can be contractually delegated to an authorized representative — but that delegation does not remove the manufacturer's ultimate legal responsibility. Importers are not required to physically hold the entire technical file, but must guarantee that they can access it from the manufacturer within a reasonable time on request; otherwise, the manufacturer's legal responsibilities can extend to the importer as well. Expectations for distributors are more limited, but no link in the chain can avoid responsibility simply by saying "we know nothing about the technical file."

Retention Period and Responsibility

Under the Machinery Directive and similar legislation, the general rule is that the technical file must be kept for at least 10 years from the date the product is placed on the market. This means the manufacturer must be able to present the file even long after production of the product has ceased. In practice, many companies set an even longer internal retention policy due to possible product liability claims and warranty processes. It is not enough for the file to simply "exist" — it must be capable of being presented, complete and understandable, within a reasonable time (typically a matter of days) on request. This is why it is critical to formally define, within the organization, where the file is kept, by whom, and under what version control.

Confidentiality and Sharing Rules

Because the technical file can contain the manufacturer's know-how, the legislation does not require it to be freely disclosed to the public. The file is kept primarily to respond to inspection requests from competent market surveillance authorities; it is not a document intended for the general public or competitors. Notified bodies are also obligated to protect confidential information in the files they review. This balance protects manufacturers' trade secrets while still ensuring effective market surveillance.

Relevant Directives and Standards

The concept of the technical file appears with different names and details depending on the directive applied to the product. Under Directive 2006/42/EC on machinery, which underlies the Machinery Regulation, the technical file is defined in Annex VII; this directive is being progressively replaced by Machinery Regulation (EU) 2023/1230, which will apply in full from 20 January 2027. The Low Voltage Directive 2014/35/EU also imposes similar technical documentation requirements within its own scope; for products with electronic communication capability, the Radio Equipment Directive (RED) 2014/53/EU also applies. All these directives follow a common structure aligned with the New Approach framework — Regulation (EC) 765/2008 and Decision 768/2008/EC — which is why the core logic of the technical file is largely similar across directives, with differences appearing mainly in content details and product-specific testing requirements.

Step by Step

1. Determine the applicable directive(s) and the technical file requirements within them.
2. Clarify the product's general description, intended use and variant scope.
3. Take stock of existing technical drawings, diagrams and calculations.
4. Identify missing document items (test reports, validation records, standard references, etc.).
5. Include the risk assessment report in the file.
6. Add the list of applied harmonized standards to the file.
7. Place copies of the user manual and EU declaration of conformity in the file.
8. Formally define the file's version control, access rights and retention period within the organization.

Most Common Mistakes

• Assuming the technical file consists only of the user manual.
• Leaving the file incomplete after the product launches, on the assumption "we'll need it someday."
• Failing to keep the risk assessment report synchronized with current design revisions.
• Not including conformity evidence for subsystems purchased from suppliers.
• Not setting up version control to track which version of the file is current.
• Treating the 10-year retention period as only "does the document exist," ignoring accessibility.
• Not designating an authorized person who can present the technical file during an inspection.

Frequently Asked Questions

Conclusion

The technical file is the invisible but most critical part of CE marking. It is not a single document — it is a comprehensive engineering archive proving the product's safety, and if it is not prepared in full, the legal assurance behind the CE marking weakens as well. For practical steps on how to prepare a technical file, we recommend our guide, How to Prepare a Technical File?