Our compliance documents are scattered everywhere

Scattered files are not a legal category, but the duties they put at risk are. Under the General Product Safety Regulation (EU) 2023/988, the manufacturer carries out an internal risk analysis and draws up technical documentation before placing a product on the market (Article 9(2)). It must ensure the documentation is up to date, keep it at the disposal of market surveillance authorities for 10 years after the product has been placed on the market, and make it available on request (Article 9(3)). Importers keep a copy for 10 years after they placed the product on the market (Article 11(6)). Under Article 2(1), third subparagraph, point (b), Chapter III Section 1, which holds these articles, does not apply to products subject to Union harmonisation legislation; for those products the act's own file rules apply.^[1]

The CE directives set the same pattern. Under the Low Voltage Directive 2014/35/EU the manufacturer draws up the technical documentation in Annex III and keeps it with the EU declaration of conformity for 10 years (Article 6(2) and (3)). Annex III point 4.2 asks for the declaration to be drawn up for a product model and kept together with the technical documentation. On a reasoned request the manufacturer provides all information and documentation, in paper or electronic form, needed to demonstrate conformity (Article 6(9)). An importer keeps a copy of the declaration and ensures the technical documentation can be made available (Article 8(8)).^[2]

The person who answers the authority is often not the person who holds the files. For products under the acts listed in Article 4(5) of Regulation (EU) 2019/1020, a product may be placed on the market only if an EU-based economic operator is responsible for verifying that the declaration and the technical documentation have been drawn up, keeping the declaration available and ensuring the file can be made available on request (Article 4(1) and (3)(a)). That operator also provides the documentation in a language the authority easily understands (Article 4(3)(b)). For GPSR products whose manufacturer is outside the Union, the responsible economic operator also checks regularly, where appropriate to the risks, that the product conforms with the technical documentation, and, on request by the market surveillance authorities, provides documented evidence of the checks performed (GPSR Article 16(2)).^[3][1]

Authorities do not have to wait for you to find the files. Article 14(4)(a) of Regulation (EU) 2019/1020 gives them the power to require documents and data on compliance in any form or format, irrespective of the medium of storage or the place where they are stored, and to take copies. If the evidence cannot be produced, the authority can require corrective action, including rectifying formal non-compliance, and ensure withdrawal, recall or a prohibition when the operator does not act (Article 16(3) and (5)).^[3]