CE Marking Technical Documentation: Contents, Risk Assessment and Retention

Technical documentation, commonly called the technical file, is the evidence behind a manufacturer’s declaration of conformity. Authorities ask for it, and manufacturers often can’t produce it in full. This article sets out what CE marking technical documentation should contain, where files commonly fall short and how long they must be kept.

What is a technical file for CE marking?

A technical file is the set of documents proving a product meets the EU rules that apply to it. The manufacturer prepares it before placing the product on the market, and the declaration of conformity relies on it. Market surveillance authorities can ask to see it.

Contents vary by the legislation that applies, so this is the general pattern, not a list for every product. Machinery manufacturers currently work to Annex VII of Directive 2006/42/EC, which Regulation (EU) 2023/1230 replaces on 20 January 2027. The same duty applies to any non-EU manufacturer, whether in India, Nigeria, Kenya, the Philippines, Oman, the USA or New Zealand, across machinery, electrical equipment, toys, building products and pressure equipment. Medical devices follow their own rules.

What should CE marking technical documentation contain?

In general: a product description, drawings and explanations, the standards applied, calculation and test results, the risk assessment, instructions for use and the declaration. Notified body certificates are added where one was involved, and production-control details for series manufacture. Every variant covered must appear.

Product description. Enough to identify the product, including every variant covered.

Drawings and explanations. Design and manufacturing drawings, schematics of components, sub-assemblies and circuits, and the notes needed to understand them.

Standards. Harmonised standards applied in full or in part, with references. Where one wasn’t applied, the solution adopted instead.

Calculations and tests. Design calculations, examinations and test reports, including external laboratory reports.

Risk assessment. The hazards, the risks and how each is addressed.

Instructions and safety information. In the required languages.

Declaration and certificates. The declaration of conformity, plus notified body certificates and reports where relevant.

Production control. For series production, how conformity of production is ensured.

Why is the risk assessment the central document?

For machinery and many other product categories, the risk assessment isn’t a formality. It identifies hazards across the product’s life, including foreseeable misuse, and shows risks were reduced by design where practicable. Guarding comes next, and information for use covers only the residual risk.

Assessors tend to read it early, because it shows whether safety was designed in or documented afterwards. A conclusion that a hazard is handled by a warning in the manual, where a design change was available, doesn’t meet the requirement.

Foreseeable misuse is the point most often under-addressed. It covers use the instructions don’t intend, but that readily predictable behaviour could produce. Products get used by tired, untrained and hurried people, and the design and instructions should allow for that.

Where do technical files fall short?

Files usually fail in the same few places: they’re assembled after the fact, test reports don’t match the product, standards are listed but not applied, variants are missing or conformity of production isn’t shown. Many also can’t be found years later.

Before: the file of a made-up Indian pump maker cites a March prototype test report, while production moved to a different motor in June.

 After: a retest on the production motor, or a recorded justification for reading across, sits beside the report.

A file assembled after the fact shows a chronology that couldn’t have happened, such as test dates later than production dates. A list of harmonised standards at the front proves nothing without evidence the product was assessed against their clauses. A file covering one model while the declaration covers a range leaves the other models unsupported.

How long must the technical file be kept, and where?

Keep the technical documentation for 10 years from the date the product is placed on the market, unless the rules for the product say otherwise. It must also be available to market surveillance authorities on request. Instructions have their own language rules, set by the member states where the product is sold.

Companies that change systems, move premises or lose the engineer who held the file often find the gap too late. Indian manufacturers often hold excellent English documentation but no translated instructions, which is a straightforward nonconformity. Under the Machinery Directive, the file needn’t be in the EU, but it must be producible quickly.

How can a manufacturer check that the file is ready?

Ask whether a complete file could be handed to an authority tomorrow, within the time allowed, covering every declared variant. If the answer involves finding things, asking a former employee or rebuilding records, the file doesn’t yet exist in the way the law means.

Run the check once a year and after every design change.

How do CE marking consultants play a main role in the file?

CE marking consultants help decide what the file must hold for a given product, test it against the applicable law and standards, and close gaps before an authority or customer finds them. The best time to involve them is during design, while changes are cheap.

MSCi’s team reads the risk assessment first and the standards list second, then asks for the evidence behind every standard claimed. Good CE marking consultancy services also leave a manufacturer’s team able to update the file when the design changes. The declaration and the file stay with the manufacturer.

How can MSCi help with your technical file?

MSCi is a consultancy, so we prepare your technical file for conformity assessment and for any authority request. The file and the declaration stay yours. With 40+ years in ISO consultation, our team reviews your file against the applicable law, finds gaps and helps you close them.

We usually begin with a short review of contents, test reports, standards evidence and variants, then share a plain list of gaps. If your file is already sound, we’ll tell you.

Frequently asked questions

1. Is a technical file the same as technical documentation?

Yes, “Technical file” is the everyday name for the technical documentation behind a declaration of conformity. Some laws use one term, some the other.

2. What’s the most common gap in a technical file?

The risk assessment is the part most often thin, followed by test reports that don’t match the production product. Both are easier to fix during design than after a customer asks.

3. Do I need CE marking consultants to build the file?

Not by law. CE marking consultants help you decide what the file must hold and spot gaps early. ISO certification consultants can help with related quality systems, but the file’s contents follow the CE rules for your product.

4. Do Indian exporters have to translate the instructions?

Instructions must meet the language rules of the member states where you sell. Check the rules for your product and each market.

5. How does MSCi support technical file reviews?

MSCi reviews your file against the applicable law, flags gaps and helps you close them before conformity assessment. The file and the declaration stay yours.

6. Can I keep the file in India?

Under the Machinery Directive, the file doesn’t have to be in the EU, nor kept in paper form. You must still produce it quickly on request.