Machinery Regulation (EU) 2023/1230: what changes from 20 January 2027 and how to prepare

Instructions for use in digital format

For the first time, instructions for use may be supplied in digital format instead of on paper (Article 10(7)). They must still be in a language easily understood by users in the Member State of destination. The manufacturer has to state on the machine, on its packaging or in an accompanying document how to access the digital instructions, must make them downloadable and printable, and must keep them available online for the expected lifetime of the machine and in any case for at least ten years after it is placed on the market.

Two duties towards the user remain. If the customer asks for paper instructions at the time of purchase, the manufacturer must supply them free of charge within one month. For machines intended for non-professional users, or that may reasonably be used by non-professionals, the essential safety information must still be delivered on paper.

In practice the manufacturer must be able to prove, for every machine and every version of the manual, that the instructions were accessible, in which version, and from when. A PDF uploaded to a corporate website that is rebuilt every three years is not a ten-year guarantee.

EU declaration of conformity reachable online

The EU declaration of conformity no longer has to physically accompany every machine (Article 10(8)). The manufacturer may indicate in the instructions an internet address or a machine-readable code, such as a QR code, where the declaration can be consulted. The availability rule applies here too: the link must keep working for the entire life of the machine.

Technical file: ten years, always available

The technical documentation and the EU declaration of conformity must be kept for at least ten years after the machine is placed on the market (Article 10(3)) and made available to market surveillance authorities on request. The file, defined in Annex IV, includes the general description, drawings, calculations, test results, the risk assessment, the list of essential requirements applied, the harmonised standards used and the instructions. For machines with software and control systems the file must also document the safety logic and, where the behaviour of the machine may evolve, how that happens.

Ten years is longer than the average life of a management system, of a server and often of a supplier. The question is not "where do I save the file" but "where will this file be in eight years, in which version, and who will still be able to open it".

Protection against corruption and tampering

The Regulation adds protection against corruption to the essential safety requirements (Annex III, point 1.1.9): the machine must be designed so that a connection to another device, or unauthorised access to the software, does not create hazardous situations, and safety-related hardware and software components must be protected against accidental or intentional alteration. Where relevant to safety, the machine must record evidence of legitimate and illegitimate interventions on those components, and safety software must be traceable through its versions and updates (point 1.2.1). This too is documentation: logs, firmware versions, update records.

High-risk machinery and third-party assessment

Annex I, Part A lists the categories of machinery whose conformity must be verified by a notified body, with no self-certification possible. Six categories are covered: removable mechanical transmission devices and their guards, vehicle servicing lifts, portable cartridge-operated fixing tools, and the two new categories, safety components with fully or partially self-evolving behaviour using machine learning that perform safety functions, and machinery embedding such a system. For these categories the technical file is examined directly and must be well ordered, complete and traceable.