Technical File for CE Marking: Content, Evidence, Retention

What is a technical file for CE marking?

EU product laws set essential requirements, and the CE marking and the EU Declaration of Conformity (DoC) claim that your product meets them. The technical documentation is the evidence behind those claims. If a market surveillance authority has a doubt about your product, this file is the first thing it will ask for.

The manufacturer prepares the file. This stays true when design, testing or writing is outsourced to consultants, laboratories or suppliers. The responsibility for the content stays with you. Other operators have related duties:

• An EU authorised representative can be mandated to keep the documentation at the disposal of the authorities.
• An importer must check that the manufacturer has drawn it up and must be able to make it available on request.
• If you buy a complete design and sell it under your own name, you become the manufacturer, and the file becomes your responsibility.

The file must be ready before the product is placed on the market. Placing on the market happens unit by unit, at the moment each product is first made available in the EU. In the simplest procedure, internal production control (module A), drawing up the documentation is one of the steps of the conformity assessment itself. You cannot ship first and complete the file later.

What must the technical documentation contain?

Decision No 768/2008/EC contains the reference modules for conformity assessment. Module A includes a list of what the technical documentation must contain, and most product laws, such as the Radio Equipment Directive (RED) or the RoHS Directive, repeat it with small adaptations. The list applies "wherever applicable":

1. A general description of the product, including its intended use and its main versions or variants.
2. Conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits.
3. The descriptions and explanations needed to understand those drawings and the operation of the product.
4. A list of the harmonised standards applied in full or in part, and a description of the other solutions used where standards were not applied.
5. Results of design calculations made and examinations carried out.
6. Test reports.

Across the whole list, the file must also include an adequate analysis and assessment of the risks. Not every item makes sense for every product. A simple cable does not need software documentation. If an item is missing, you should be able to explain why it does not apply. A short written justification for each omitted item also shows you have not simply forgotten something.

For the first three items, the test is simple. A competent engineer who has never seen the product should understand how it is built and how it works. Photos, block diagrams and a short description of each operating mode often help more than hundreds of pages of unexplained drawings.

The standards list matters because the presumption of conformity covers only the requirements that an applied harmonised standard actually addresses. If you applied a standard only in part, say which parts. Our guide to harmonised standards and presumption of conformity explains this in detail.

Machinery: Annex VII and Annex IV

Directive 2006/42/EC sets out the technical file for machinery in Annex VII, part A. It applies until 19 January 2027. It asks for a general description, an overall drawing, control circuit diagrams with explanations, detailed drawings, calculation notes and test results. It also asks for:

• the documentation of the risk assessment, with the list of applicable essential health and safety requirements and the protective measures adopted;
• the standards and other technical specifications used;
• a copy of the instructions and of the declaration of conformity;
• where relevant, declarations of incorporation of partly completed machinery and declarations of conformity of other incorporated products;
• for series manufacture, the internal measures that keep each unit in conformity.

Machinery placed on the market from 20 January 2027 follows Regulation (EU) 2023/1230. Its Annex IV sets out a very similar list, and adds points such as safety-related software and protection against corruption, which links to cybersecurity. Read Annex IV directly and check the latest Commission guidance before you update your template. Our Machinery Regulation course covers the transition.

How do you document the risk assessment?

Essential requirements are written in general terms. They say that moving parts must be designed to prevent risks of contact, not which guard to fit. Only the risk assessment shows which requirements are relevant to your product and what they mean in practice. For machinery, the risk assessment is an explicit obligation of the manufacturer.

EN ISO 12100, the basic safety standard for machinery, is also a useful model for many other products. It describes an iterative process:

1. Determine the limits: intended use, reasonably foreseeable misuse, users, phases of life and space occupied.
2. Identify the hazards in every phase of life, from transport to dismantling.
3. Estimate the risk for each hazardous situation, considering severity and probability of harm.
4. Evaluate whether the risk is adequately reduced or needs further measures.

Risk reduction follows the three-step method: inherently safe design first, then safeguarding and complementary protective measures, then information for use. A warning label cannot replace a guard that was technically possible. After each measure, check that it works and that it does not create new hazards.

Residual risks must appear in the instructions, together with what the user must do about them. If the risk assessment and the instructions tell different stories, an inspector will notice quickly.

Which test reports and component evidence do you need?

Test reports can come from your own laboratory or an external one. Both are acceptable if the tests follow the relevant standard and the report is complete and traceable. Each report should identify the product tested, its version, the standard and edition used, and the result. Reports from laboratories accredited to ISO/IEC 17025 are not required by the product laws, but they carry weight. If you test in-house, keep records of equipment calibration and staff competence.

Supplier evidence is part of your file. Typical examples are:

• declarations of conformity of components that carry their own CE marking;
• RoHS declarations or material data for parts and sub-assemblies;
• certificates for safety components;
• test reports of an integrated radio module.

Collect these documents during purchasing and read them. Check that they cover the exact part number, the right law and a standard edition that is still valid. Integrated components need extra care. A radio module tested on its own can behave differently once integrated, because the antenna position, power supply and enclosure change. Supplier evidence supports your assessment, but you still assess the product as a whole.

How long must you keep the technical file?

The general rule in the New Legislative Framework (NLF) is ten years after the product has been placed on the market, unless the specific law says otherwise. Some laws use a different wording. The Machinery Directive counts ten years from the date of manufacture or, for series production, from the last unit produced. For machinery made over many years, this means keeping each version of the file for ten years after the last unit of that version left the factory. For other products, count from the placing on the market of the last unit of that version. Choose file formats you will still be able to open.

Market surveillance authorities can see the file on a reasoned request, for example after an accident or a complaint. Customers and distributors have no general right to it. It contains drawings, calculations and know-how you will want to protect. Customers receive the instructions, the declaration of conformity and the information on the product. A notified body, when involved, sees the parts its module requires.

The file must be in a language the requesting authority can understand. Many manufacturers keep it in English and translate parts on request. It can be fully electronic, but you must deliver it within the time the authority sets. Agree with your EU partners in advance who receives a request and how documents reach the authority.

How should you organise the file and control versions?

Start with an index that follows the list in the law, chapter by chapter. Put the general description and the list of applicable laws at the front. Then add a cross-reference table with one row per applicable essential requirement, the measure adopted and the document that proves it. This table is the fastest way for an inspector to understand your file.

The technical documentation is a living file. A new motor, a different power supply, a software update or a new radio module can each affect conformity. Each time, check whether the risk assessment, the tests and the declaration are still valid. Practical habits that help:

• Give every document a code and a revision, and keep the index updated.
• Link each revision of the file to the product versions it covers.
• Archive superseded revisions instead of overwriting them, so you can show the file as it was for a unit sold years ago.
• Keep a matrix with product versions in the columns and evidence documents in the rows.
• Check that the model name and manufacturer details match on the nameplate, the declaration, the instructions and the file.

A final test: imagine an inspector with no access to your engineers and only the file. Could that person see what the product is, which laws and standards apply, which risks you found and how each requirement is met? If the answer depends on knowledge in someone's head, there is still work to do. The EU declaration of conformity guide covers the document that closes the file, and the CE Marking Fundamentals course walks through the full route.

Key points

• The technical file is the manufacturer's evidence of conformity and must be ready before each unit is placed on the market.
• Decision No 768/2008/EC gives the general content; machinery follows Annex VII of Directive 2006/42/EC, then Annex IV of Regulation (EU) 2023/1230 from 20 January 2027.
• The risk assessment links hazards to essential requirements and explains every test.
• Every report and supplier document must be traceable to the exact product version.
• Keep the file for ten years unless the specific law says otherwise, and archive old revisions.