All you need to know about CE Marking
CE Marking Technical File: What It Must Include and Who Prepares It
If you are a US manufacturer preparing to sell products in the European Union, at some point you will hear the words “technical file.” And if you are like most American companies entering the EU market for the first time, your first question will be: what exactly is this, and who is supposed to put it together?
This post answers both questions in plain terms, so you know what to expect before you start the CE marking process.
What is a CE marking technical file?
A CE marking technical file is the collection of documents that proves your product meets the essential requirements of the EU directive or regulation that applies to it. It is not a certificate.
No authority issues it, stamps it, or approves it in advance. You build it, you own it, and you keep it.
If market surveillance authorities ask to see it, you hand it over. If it is incomplete or inaccurate, you bear the consequences.
This is an important point to understand, because a number of CE marking consultants are selling what they call a “compliance report”: a document in which they analyze the product and justify its conformity with the applicable directive. This is not illegal in itself, and in some cases it can be useful to share with a potential client or distributor as a summary of the compliance work done. But it does not replace the technical file. Market surveillance authorities will not accept a compliance report as evidence of compliance. The technical file is the only document that counts, and there is no shortcut around it.
Is a technical file required for all CE marked products?
Yes, always. Every product that carries the CE marking must have a technical file behind it, regardless of the directive involved or whether the conformity assessment required a Notified Body.
What changes between products and directives is the content and depth of the file. A simple low-voltage appliance and a complex piece of industrial machinery will both need a technical file, but the machinery file will be significantly more extensive.
Understanding which directives apply to your product is the first step, because that determines the structure and requirements of the file you need to build.
What must a CE marking technical file include?
There is no single universal template, because the content depends on the applicable directive. That said, a complete technical file for a physical product will typically cover the following:
General description and intended use. A clear explanation of what the product is, what it does, and the conditions under which it is meant to operate. This sets the scope for everything else in the file.
Detailed photos. Visual documentation of the product as it will be placed on the market, including all relevant views and any safety-critical components.
Applicable directives and harmonized standards. A list of the EU directives and regulations the product must comply with, and the harmonized European standards used to demonstrate that compliance. This is where using American standards such as UL or ANSI instead of EN standards is a common and costly mistake.
Essential Health and Safety Requirements (EHSRs) checklist. A structured review of each essential requirement in the applicable directive, documenting how the product addresses it. This is one of the most technically demanding parts of the file.
Manufacturing drawings and calculations. Technical drawings showing the product’s design and dimensions, together with any engineering calculations supporting the design choices.
Test reports. Results from any tests carried out to demonstrate conformity with the applicable standards. These may be conducted internally or by an accredited external laboratory, depending on the directive and the product category.
Bill of Materials (BoM). A complete list of components and materials used in the product, including key suppliers and any safety-relevant specifications.
Risk assessment. A systematic analysis of the hazards associated with the product and the measures taken to eliminate or reduce them. A superficial risk assessment, or one copied from a similar product without proper adaptation, is one of the most frequent reasons technical files fail scrutiny.
Component information. Documentation on key components, including any certifications or approvals they carry that are relevant to the product’s compliance.
Warning signs and labeling. Evidence that the product carries all required markings, warnings, and labels in the correct format and language for the target market.
Name-plate. Documentation of the product identification plate, including the information required by the applicable directive (manufacturer name, model, serial number, CE marking, etc.).
User’s manual. The instructions for use in the official language or languages of the countries where the product will be placed on the market.
Declaration of Conformity (DoC). The formal document in which the manufacturer declares that the product meets all applicable EU requirements. This is signed by the manufacturer and kept as part of the file. A copy is usually provided with the product for Customs purposes.
How long must you keep the technical file?
The general rule is ten years from the date the product was last placed on the market, though some directives specify different periods. During that time, the file must be available for inspection if requested by national market surveillance authorities.
This obligation falls on the manufacturer. If your company is based outside the EU, it falls on your EU Authorised Representative, who holds a legal responsibility for making the file accessible to authorities on your behalf.
Who prepares the CE marking technical file?
The manufacturer is legally responsible for the technical file. Who actually puts it together in practice depends on the company’s internal resources and experience with EU requirements.
Some companies with strong engineering teams and prior experience with EU directives handle the file internally. Others bring in an external CE marking consultant to lead the process or fill specific gaps, particularly around the risk assessment, the EHSRs checklist, or the selection of applicable harmonized standards. In many cases, the most effective approach is a combination: the manufacturer provides the technical content, and the consultant structures and validates the file against the directive requirements.
Once the file is structured, the work does not stop there. In the second phase of a CE marking project, the focus shifts to managing the open actions: coordinating tests, closing gaps in the EHSRs, finalizing drawings, and tracking the overall progress toward the Declaration of Conformity. This is where a Gantt chart becomes a useful tool — not as a permanent part of the technical file, but as a shared workspace between the consultant and the manufacturer to keep the project moving. Consultant and client work from it together during the project, in a folder that lives alongside the file while the work is in progress. Once the project is closed and the file is complete, the Gantt chart has served its purpose. What remains is the finished technical file, without it.
Common mistakes US manufacturers make with the technical file
Using American standards instead of harmonized European standards. UL and EN standards often cover similar ground but are not interchangeable. A technical file that references UL standards without mapping them to the corresponding EN harmonized standards will not satisfy a CE marking audit.
A risk assessment that does not hold up to scrutiny. This is the most technically demanding document in the file. A generic template, a copy from a previous product, or a superficial analysis that does not address the specific hazards of the product will be immediately visible to a reviewer.
An incomplete file at the time of market surveillance. Authorities can request the technical file at any point during the ten-year retention period. A file that was “good enough to start selling” but never fully completed is a serious liability.
Not updating the file when the product changes. If you modify the product after CE marking — even a component substitution that seems minor — the technical file must be reviewed and updated. The DoC is only valid for the product as it was assessed.
Treating a compliance report as a substitute for the technical file. As mentioned at the start of this post, a compliance report prepared by a consultant is not the technical file. If market surveillance authorities come knocking, the report will not be what they ask for.
Ready to build your technical file?
The technical file is the foundation of CE marking compliance. Getting it right from the start avoids delays, retesting costs, and legal exposure if your product is ever inspected.
If you are not sure where to start, or if you need an experienced partner to structure and complete the file alongside your team, our CE marking consulting service is designed exactly for that.
Category: CE Marking