An authority asks for our technical documentation

The technical documentation is written for exactly this moment. Under the General Product Safety Regulation (EU) 2023/988, the manufacturer draws it up before placing the product on the market, keeps it up to date, keeps it at the disposal of market surveillance authorities for 10 years and makes it available to them upon request (Article 9(2) and (3)). The Commission's Blue Guide counts such periods from the last unit of the model placed on the market (footnotes 115 and 142). Importers keep a copy for the same 10 years and ensure that the documents can be made available on request (Article 11(6)). For products subject to Union harmonisation legislation, the GPSR's Chapter III, Section 1 (Articles 9 to 18) does not apply, and the act's own documentation rules apply instead (Article 2(1), third subparagraph, point (b)).^[1]

The CE directives set the same duty in their own words. Under the Low Voltage Directive 2014/35/EU, the manufacturer keeps the technical documentation and the declaration for 10 years (Article 6(3)) and, on a reasoned request, provides all information and documentation in paper or electronic form, in a language easily understood by the authority (Article 6(9)); the importer keeps a copy of the declaration and ensures the technical documentation can be made available (Article 8(8)). Annex III lists what a Module A file contains: a general description, design and manufacturing drawings, the explanations needed to understand them, the standards applied, design calculations and examinations, and test reports, together with an adequate analysis and assessment of the risks. The Radio Equipment Directive 2014/53/EU adds that where the documentation fails to present sufficient data, the authority may ask the manufacturer or the importer to have a test performed at their expense (Article 21(4)).^[4][5]

The toy directive is the most specific about timing. The technical documentation may be drawn up in any official language of the Union, subject to Article 20(5); on a reasoned request the manufacturer provides a translation of the relevant parts into the language of that Member State. The authority may fix a deadline of 30 days for receipt of the file or the translation, unless a shorter deadline is justified by a serious and immediate risk (Directive 2009/48/EC Article 21(2) and (3)). If the manufacturer does not comply, the authority may require a test by a notified body at the manufacturer's expense (Article 21(4)).^[3]

Behind every request stand the authority's general powers. Regulation (EU) 2019/1020 lets it require economic operators to provide documents, technical specifications, data and information on compliance, in any form and wherever stored, and to take copies (Article 14(4)(a)). For products under the acts listed in Article 4(5), the economic operator established in the Union must answer a reasoned request with all information and documentation needed to demonstrate conformity, in a language the authority easily understands (Article 4(3)(b)). A missing or incomplete file can lead to an order to rectify and, failing that, to withdrawal or recall (Article 16(3) and (5)).^[2]