Machinery Regulation: no compliant manuals, no CE mark from 14 January 2027

On 14 January 2027 the Machinery Directive 2006/42/EC — the rule on which Italian industry has built twenty years of technical files — stops producing effects. In its place, Regulation (EU) 2023/1230, of 14 June 2023, published in the EU Official Journal on 29 June 2023 and in force since 19 July 2023 (Article 54), applies in full. Article 51 repeals, from the same date, the 2006/42/EC directive and the older Directive 73/361/EEC on wire ropes, chains and hooks. That gives 42 months in which every manual has to be rewritten under new rules, because whatever is placed on the market from 14 January 2027 already answers to the regulation, not to the directive it replaces. Of all the changes, the one that touches every manufacturer — general engineering or special-purpose machinery alike — is the chapter on instructions for use: that is where CE marking will be won or lost after 2027.

Instructions go digital, but not on a whim

Directive 2006/42/EC treated the manual as a paper attachment by default: electronic format was a concession, not the rule. Article 10(7) of Regulation (EU) 2023/1230 flips that: the manufacturer may supply instructions exclusively in digital format, provided they remain available online for the machine’s expected lifetime and, in any case, for at least 10 years from placing on the market — even if the manufacturer ceases trading in the meantime. That is not a technicality: it is a documentary-continuity obligation to design for, not to improvise in the final month.

The same provision sets two hard limits no manufacturer can ignore: if the purchaser requests it at the time of purchase, the manufacturer must supply a free paper copy within one month; and for non-professional users, safety information must always remain on paper. Digital-only is therefore a real option for industrial B2B supply, not a universal shortcut for cutting print costs.

What the manual must contain, and in which language

The minimum content is still governed by Annex III, point 1.7.4 (sub-sections 1.7.4.1 and 1.7.4.2): manufacturer identification, description of the machine, intended use and reasonably foreseeable misuse, assembly instructions, commissioning, use, maintenance, residual risks. Language remains a firm constraint: under Article 10(7), instructions must be drawn up in a language established by the Member State of use, easily understood by end users — machine-translating a manual “well enough” for a multilingual market like the EU’s remains a compliance risk, not a marketing detail.

Software, AI and cybersecurity in the essential requirements

The most novel part of the regulation, and the least reported one, concerns what sits behind the manual: control software. Annex III, point 1.1.9 introduces a requirement absent from Directive 2006/42/EC — protection against corruption: connecting the machine to another device, even remotely and even via the internet, must not be able to create a hazardous situation; hardware, software and data relevant to safety must be protected against accidental or intentional corruption. Point 1.2.1 strengthens the safety of control systems against malicious external attempts too, with additional requirements for machines exhibiting “self-evolving behaviour or logic” — the wording with which the regulation captures, without ever naming them, AI systems with machine learning built into the machine’s safety function.

That is not an isolated detail: Annex I, Section A, of Regulation (EU) 2024/1689 (the AI Act) lists Regulation (EU) 2023/1230 among the Union’s harmonisation legislation. An AI system acting as a safety component of a machine subject to third-party conformity assessment therefore automatically becomes “high-risk” under the AI Act, with the full apparatus of documentation and oversight that follows — the same obligations the GPAI Act places on providers of general-purpose models. Anyone designing a machine with AI built into its safety today is already building an AI Act system, even if no one in the company calls it that yet.

Who answers for it, across the whole chain

The obligations do not stop at the manufacturer. Article 10 governs manufacturers of machinery and related products; Article 11 does the same for manufacturers of partly completed machinery, with assembly instructions for whoever integrates it into a larger installation. Article 13 requires the importer to verify, before placing the product on the EU market, that the manufacturer has carried out the conformity assessment, compiled the technical file, drawn up the declaration of conformity and the manual, and affixed CE marking: if anything is missing, the importer cannot place it on the market. Articles 15-16 require the distributor to check that CE marking, EU declaration of conformity and instructions genuinely accompany the product, with model, type, year of construction and manufacturer’s or importer’s details legible: responsibility for the manual is never exhausted in a single link of the chain.

The practical consequence: no compliant manual, no CE marking

The point many Italian manufacturers underrate is simple: instructions are not an attachment to the declaration of conformity, they are an integral part of it under the essential requirements of Annex III. A machine placed on the market from 14 January 2027 with a manual written to 2006/42/EC criteria — paper only, outdated content, no mention of cybersecurity where relevant — cannot receive a valid declaration of conformity. No declaration, no CE marking; no CE marking, no single market. This is not a penalty that arrives after an inspection: it is a structural block, on the very day of the supposed placing on the market.

The manual is an asset, not a document to hand over

There is a second problem the regulation does not address but every technical office knows well: the manual contains, often without anyone having decided so at board level, the company’s know-how — calibration parameters, maintenance cycles, safety thresholds built from years of field experience. That is exactly the kind of information that Directive (EU) 2016/943 and Legislative Decree no. 63 of 11 May 2018, amending Articles 98-99 of the Italian Industrial Property Code, classify as a protectable trade secret — provided it is secret, has economic value precisely because it is secret, and is subject to measures reasonably adequate to keep it secret. A manual circulating by email to external consultants, notified bodies and sales offices, with no defined perimeter, quietly stops meeting that third condition — and with it, the protection.

Checking hundreds of pages of instructions against the points of Annex III, the cybersecurity requirements and the required languages, without letting those documents leave the company perimeter, is work our manufacturing engagements now carry out with dedicated, closed AI, in two modes of the client’s choosing: installed on-premise inside their own environment, or delivered from our dedicated cloud — an environment reserved for the individual client, accessed over a dedicated VPN, on a data centre resident in Italy, on premises we staff and supervise directly. In both cases the AI is disconnected from the open web: it reads the manual, flagging exactly where the text fails to cover an Annex III requirement or omits the digital-format clause, and suggesting the fix — in a fraction of the time an internal technical office would need working manual by manual. That is the principle our platform is built on: compliant with the future already today, updating the documentation pipeline now instead of chasing January 2027 machine by machine. The same method also serves those who have already worked on predictive maintenance in Emilia’s industrial districts or on Cyber Resilience Act reporting duties: technical documentation, reviewed properly once, settles more than one obligation at a time.

Want to know how many of your manuals would pass an Annex III check today? A 30-minute operational trial with one of our experts is enough for the first map.