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Operational notes Regulation

The harmonised standard on the manual has existed since 2020: almost no one cites it

7 min read

A page of printed sheet music, dense rows out of focus except the central fold, black-and-white photograph
In a list of nearly a hundred rows, only one gives presumption of conformity for the manual. The others get read; this one gets applied.

Whoever writes machinery manuals cites almost always the same standard: IEC/IEEE 82079-1:2019, the standard on which technical-communication professionals train across half the world. In the list of harmonised standards supporting the Machinery Directive 2006/42/EC, though, IEC/IEEE 82079-1:2019 does not appear — in any version, ever. There is another standard, one almost nobody names, that has appeared for six years: “EN ISO 20607:2019”, row 94 of the latest list published in the EU Official Journal. It is that one, not the other, that gives presumption of conformity: the difference between the two is not one of professional prestige, it is one of legal effect, and it is written row by row in a public document.

Row 94, verified twice

Commission Implementing Decision (EU) 2023/1586, of 26 July 2023, lists in Annex I, part two (type B standards), the references of harmonised standards supporting the Machinery Directive. Row 94 reads, verbatim, in the Italian-language Official Journal text: «EN ISO 20607:2019» — «Sicurezza del macchinario - Manuale di istruzioni - Principi generali di redazione (ISO 20607:2019)» — Safety of machinery - Instruction handbook - General drafting principles (ISO 20607:2019). It is not the first appearance: the same standard enters the list three years earlier, at row 66, with Commission Implementing Decision (EU) 2020/480 of 1 April 2020 — same title, same type B classification. Six years of presumption of conformity, not a few months.

Recital (9) of Decision 2020/480 explains why that row carries no note: «non occorre aggiungere limitazioni all’atto della pubblicazione di tali norme» — there is no need to add limitations when publishing those standards. Decision 2023/1586’s structure confirms it: Annex I gives only number and title, no column for conditions or limitations — that column exists elsewhere, but records withdrawal dates for superseded standards, not reservations on ones in force. We checked the full text, not just the row: no asterisk, note or footnote reference appears anywhere in the document.

What is not there, verified with grep

On the standard everyone cites, the count runs the other way. We searched for “82079”, case-insensitive, in the published text of Decision 2023/1586 and in all seven of its consolidated versions on EUR-Lex, from 30 April 2024 to 15 May 2026: zero hits in all eight. The count holds as proof only because each of the eight files contains “20607” — row 94 — which shows it is the right document and not an empty or error page: the trap that makes half of such searches worthless. IEC/IEEE 82079-1:2019 has never entered the list of harmonised standards supporting the Machinery Directive, in any of the eight versions published from 2023 to today.

Two catalogues, one limit we do not work around

The full text of both standards is paywalled, and we have not read it: neither body publishes it free of charge, and a preview page is no substitute. What follows comes only from the official catalogues, never from the substance of the standards. The ISO catalogue records “ISO 20607:2019 - Safety of machinery — Instruction handbook — General drafting principles”, edition 1, published in June 2019, 24 pages, status “Published”, already flagged “to be revised”. The IEC catalogue records “IEC/IEEE 82079-1:2019”, title “Preparation of information for use (instructions for use) of products - Part 1: Principles and general requirements”, edition 2.0, published on 16 May 2019, 130 pages, status “PUBLISHED”, with a third edition already under development. We add nothing else: how the two standards treat the manual on the merits stays behind a paywall we did not clear.

Article 20: why the difference is legal

The two spec sheets above would be no more than a bibliographic curiosity if Regulation (EU) 2023/1230 — which replaces the Machinery Directive from 20 January 2027 — did not tie a precise effect to publication in the Official Journal. Article 20(1) puts it this way: “A product within the scope of this Regulation which is in conformity with harmonised standards […] the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those standards […]”. That is the presumption of conformity: applying the harmonised standard is enough, with no need to demonstrate conformity any other way for the requirements it covers. EN ISO 20607:2019 gives that effect to whoever writes the instruction handbook; IEC/IEEE 82079-1:2019 does not — whatever it says on the merits, whatever community of practitioners treats it as the reference on method.

Between now and 20 January 2027

The Regulation applies from 20 January 2027 — not the 14th, as the uncorrected CELEX text still states: we verified this in an earlier piece, and it holds here too. Until that date the 2006/42/EC Directive remains in force, and, verifiably, the Regulation has no dedicated list of harmonised standards yet: the Commission’s own page on harmonised standards for the machinery sector is still headed “Machinery (MD)”, with base act “Directive 2006/42/EC”, and lists only the decisions published in support of the Directive — including 2023/1586 and its six updates recorded up to 12 March 2026. A separate entry for the Regulation, on the same site, does not exist yet.

What this means for whoever has to check the manuals

For whoever has to check hundreds or thousands of manuals, these facts sketch out a precise space. The Regulation mandates the content: Annex III, point 1.7.4.2, titled precisely “Contents of the instructions for use”, lists the minimum information the manual must contain. It does not mandate the form: point 1.7.4.1, “General principles for the drafting of instructions for use”, stops at two general pointers on intended use and operator competence, with no drafting methodology. The harmonised standard that would cover that form exists — EN ISO 20607:2019, row 94 — but it is paywalled, and whoever wants presumption of conformity on the form of their own manual has to buy it. And no format or template is mandatory, in the Regulation or in any Commission decision: no official model to fill in. It is in this space — content mandated, form free save for the voluntary purchase of a paywalled standard, no schema imposed — that a systematic check of technical files has something to say manual by manual, not by sampling.

Article 20 is not only about manuals: the same article, with a new paragraph 10, is the bridge chosen to extend to machinery the harmonised AI standards that do not yet exist — the same absence, told from another angle. Once that check runs on the technical files, it stops being only about Official Journal rows: it pools data scattered across engineering, quality and sales on which the decisions that actually matter get made.

How many of your manuals rely on a standard that, under the Machinery Regulation, gives no presumption of conformity at all? A row-by-row check settles the difference in an afternoon.

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