Technical-file gap review

Technical documentation is the file that makes it possible to assess whether a product meets the requirements that apply to it. In the model of Decision No 768/2008/EC, Annex II, Module A, point 2, it includes an adequate analysis and assessment of the risks and covers, as far as relevant, the design, manufacture and operation of the product.

For machinery placed on the market under Directive 2006/42/EC, Annex VII of that Directive sets out the technical documentation. Regulation (EU) 2023/1230 applies from 20 January 2027 (Article 54). Until that date, Directive 2006/42/EC remains applicable. Annex IV of the Regulation is therefore not yet the applicable rule, and it covers only machinery and related products within its scope. For consumer products, Regulation (EU) 2023/988, Article 9(2), is a separate regime: it requires an internal risk analysis and technical documentation, and it does not provide for CE marking.

The manufacturer establishes the technical documentation and keeps it at the disposal of the authorities. Under Decision No 768/2008/EC, the declaration of conformity is kept together with that documentation. An authorised representative may carry out defined tasks only when a written mandate provides for them.

The file supports the manufacturer's statement of conformity. It does not transfer the manufacturer's responsibility to a laboratory, a consultant or an importer.

Where they are relevant, the NLF model asks at least for the following.

• A general description of the product.
• Conceptual design and manufacturing drawings, with the explanations needed to understand them and the operation of the product.
• The harmonised standards or other technical specifications applied in full or in part, and the solutions used where those standards are not applied. Partial application is identified.
• Results of design calculations, examinations and test reports.
• For machinery, the risk-assessment documentation, the protective measures and residual risks, a copy of the instructions, and a copy of the declaration.

These are general patterns. They are not a finding about any particular product.

• Drawings or descriptions do not match the version placed on the market.
• Standards are named, but the parts actually applied are not identified.
• The risk analysis is missing, or it is not specific to the product.
• Test reports, instructions or the declaration are absent from the file, or they concern another model.
• For partly completed machinery, the file follows the route for complete machinery.

• What is the exact product, including variants and the version placed on the market?
• What is the intended use, and which misuse is reasonably foreseeable?
• Which Union acts are believed to apply, and in which Member States?
• Which standards were applied in full or in part?
• Which drawings, risk records, reports, instructions and declarations already exist?
• Is the product complete machinery or partly completed machinery?

The obligations depend on the product and on the applicable act. The rules of the Machinery Directive, the Low Voltage Directive 2014/35/EU and the Radio Equipment Directive 2014/53/EU, including CE marking where the applicable text provides for it, are separate from Regulation (EU) 2023/988 on general consumer-product safety. There is no CE marking under that Regulation.

The exact contents depend on the act and the product. A tidy index does not show that the underlying tests were carried out. Partly completed machinery follows a different documentation route from complete machinery.

Under Regulation (EU) 2023/988, Article 9(3), the manufacturer keeps the consumer-product technical documentation for 10 years after the product has been placed on the market and makes it available to the market-surveillance authorities on request. Other acts set their own retention rule. In the NLF model, the declaration is kept with the technical documentation for 10 years after placing on the market.