Machinery Regulation: change one thing, three answers and seven silences

A cell already in production receives a safety-software update. A harmonised standard cited in the declaration of conformity gets revised. The same machine, sold for years only in Italy, ends up for the first time in another Member State. In all three cases the question is the same: besides the thing that just changed, what else needs updating? Regulation (EU) 2023/1230 does not gather the answer in one article: it writes it out in three places, leaves it to be inferred elsewhere through cross-references, and on plenty of concrete cases says nothing — E for explicit, D for derived from a cross-reference, S for silence, where propagating is a choice each company makes on its own, not a written obligation.

Three explicit answers

The sharpest is Article 10(4): the manufacturer ensures that “the necessary procedures are in place to ensure that machinery or related products manufactured in series continue to conform with this Regulation”, taking “due account” of changes to design or characteristics, “as well as of changes in the harmonised standards […] with reference to which conformity is declared”. It is a written, bounded obligation: it covers what the manufacturer is still producing. On machines already delivered the article says nothing, either way. It is the most important point in the piece, and it is a silence, not a declared exemption: no line excludes already-sold units from an update, none requires one.

The second concerns the EU declaration of conformity. Article 21(2) requires that it “shall be kept up to date and shall be translated into the language or languages required by the Member State in whose market the machinery or related product is placed on the market, made available on the market or put into service”. New Member State, new language for the declaration: the propagation is written out in full.

The third sits in the declaration’s template. Annex V, Part A, point 1, calls for identifying the “Machinery or related product (product, type, model, batch or serial number) or machinery or related product that has undergone substantial modifications”. Substantial modification — narrowly defined by Article 3(16) — has a box of its own on the form: once it applies, the document changes shape, not just content.

The software, explicitly

On software the Regulation is not silent. Annex III, point 1.1.9, requires that “the machinery or related product shall collect evidence of a legitimate or illegitimate intervention” on the hardware components carrying safety-related software: every intervention, authorised or not, leaves a verifiable trace. Point 1.2.1 adds two distinct horizons that almost no commentary keeps apart: the log of safety-software versions loaded after placing on the market stays accessible for five years after loading; decision-making data from systems with fully or partially self-evolving behaviour is kept for one year after collection. Same annex, two different durations depending on what changes: the safety software, or the behaviour of the system that decides.

The cross-reference holding the rest together

Part of the coherence between instruments comes not from a new obligation but from a cross-reference. Article 51(2) provides that “references to the repealed Directive 2006/42/EC shall be construed as references to this Regulation”. It is not a decorative clause. In the consolidated text of Regulation (EU) 2019/1020 on market surveillance as at 12 August 2026, Article 4(5) still lists Directive 2006/42/EC among the acts for which a responsible economic operator must be established in the Union, and the Machinery Regulation’s number appears nowhere in the whole instrument. Without Article 51’s cross-reference, that list would stay anchored to a repealed directive.

The same mechanism, read in reverse, explains why a resale reopens nothing. Article 3 defines “placing on the market” as “the first making available” and “putting into service” as “the first use”: events that by definition happen once. A second-hand machine that changes owner without modifications does not generate a new placing on the market, and does not on its own reactivate the obligations tied to that moment.

The same obligation, in another regulation

The Cyber Resilience Act — Regulation (EU) 2024/2847 — imposes on manufacturers of products with digital elements an almost twin clause: “the necessary procedures [are] in place to ensure that products with digital elements manufactured in series continue to conform with this Regulation”, with the same duty to take into account “changes in the harmonised standards […] with reference to which conformity of the product with digital elements is declared” (Art. 13(14)). Same textual architecture, same limit to series production.

But on a nearby point the CRA does not stay silent. Article 69(2) provides that products placed on the market before 11 December 2027 “shall be subject to the requirements of this Regulation only if, from that date onwards, […] they are subject to a substantial modification”: the explicit answer to the question the Machinery Regulation leaves open on already-sold units. Paragraph 3 goes further — the reporting obligations of Article 14 “shall apply to all products with digital elements […] that have been placed on the market before 11 December 2027”, with no modification required, and from 11 September 2026 under Article 71(2). On the already-sold, here, a sibling regulation answers where the other stays silent.

Liability looks anyway

Where the Machinery Regulation imposes nothing on what has already been sold, another text watches the same object anyway. Directive (EU) 2024/2853 on liability for defective products, to be transposed by 9 December 2026, lists among the factors a court takes into account when assessing defectiveness “the instructions for assembly, installation, use and maintenance” and “the effect on the product of its capability of continuing to learn or acquire new functionalities after it was placed on the market or put into service” (Art. 7(2)(a) and (c)). It is not an obligation to update: it is a standard of judgment, triggered only once harm has occurred.

The employer’s side

Legislative Decree 81/2008 repeats the question from the standpoint of whoever uses the machine. Article 73(2) requires informing workers «sui cambiamenti di tali attrezzature» — of changes to that equipment — the most direct hook to any event that modifies the machine, without saying within what time or in what form. Article 37(4)(c) requires training «in occasione […] della introduzione di nuove attrezzature di lavoro o di nuove tecnologie» — on the occasion […] of the introduction of new work equipment or new technologies. And Article 71(8) sets a hierarchy: the employer proceeds «secondo le indicazioni fornite dai fabbricanti ovvero, in assenza di queste, dalle pertinenti norme tecniche o dalle buone prassi o da linee guida» — according to the instructions given by manufacturers or, in their absence, the relevant technical standards, good practice or guidelines — the manual comes before the technical standard.

The seven silences

They are the most useful part, because that is where every company decides on its own.

Resale without modification. The Regulation does not say whether a change of ownership, with no physical or digital intervention, triggers checks.
Business transfer or succession of the manufacturer. The CRA requires notifying authorities and users before ceasing activity (Art. 13(23)); the Machinery Regulation has no equivalent clause.
Withdrawal of a harmonised standard’s citation from the Official Journal. Article 10(4) speaks of changes to the standard; it says nothing about a citation withdrawn while the standard itself stays the same.
The one-off, custom-built machine. The Article 10(4) obligation is written for machinery “manufactured in series”: for the machine outside series production the text neither requires nor excludes the same safeguard.
Version control of the instructions. It is not written whether the ten years of online accessibility restart with every revision of the manual, nor whether the previous version must be kept.
The component replaced below the substantial-modification threshold. If the intervention remains maintenance, the Regulation does not say who records it in the technical file, if anyone does.
The second-hand machine, from the employer’s side. If the original manufacturer can no longer be traced, Legislative Decree 81/2008 does not specify how to still make information and instructions for use comprehensible to workers.

Mapping, not guessing

A real machine fleet accumulates years of software updates, component replacements and market changes. None of these events, on its own, says which pages of the technical file need reopening: that is decided by the explicit text, the cross-references between instruments and — for the seven cases above — an internal choice no rule imposes. That is the work of assisted document compliance: a dedicated, closed AI reads technical files, manuals and declarations, and flags where an event that already happened has not been propagated into the documents meant to record it. It does not decide the seven silences for you: it shows where your practice today diverges from yesterday’s.

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