Regulations •

Digital instructions for use: when they are allowed and what must stay on paper

When instructions for use may be supplied digitally, the five conditions that come with the permission, what still has to be delivered on paper, and how the digital product passport becomes the carrier for both the manual and the declaration of conformity.

Author: myDPP Team

Digital instructions for use: when they are allowed and what must stay on paper

The printed manual is the last stack of paper in EU product law that almost nobody defends. It costs printing, storage and translation, it is out of date the moment the machine gets a software update, and it usually ends up unread in a drawer. It was mandatory for decades anyway, because product law read “accompanied by” literally.

That is changing in two steps. Sector by sector: the Machinery Regulation explicitly allows digital instructions from 20 January 2027, and for professional-use medical devices electronic instructions have been available almost across the board since July 2025. Horizontally: Omnibus IV extends the same logic to around 20 product acts and names the digital product passport as the intended place to keep the manual and the declaration of conformity.

“Digitally allowed” does not mean “put a PDF on the website and move on”. Every permission comes with conditions that together describe a data-retention problem: availability over ten years, versioning, language versions, an access route printed on the product, and a right to paper that the customer can trigger at any time. This article sorts out who may already go digital, what the conditions actually require, and what stays physical.

Key takeaways

  • The Machinery Regulation (EU) 2023/1230 explicitly allows digital instructions (Article 10(7)), applicable from 20 January 2027. Conditions: the access route must be stated on the machinery, its packaging or an accompanying document; the content must be printable, downloadable and storable locally; it must remain online for the expected lifetime of the machinery and in any case for at least ten years after it was placed on the market.
  • Anyone who asks for paper at the moment of purchase gets it free of charge within one month. That claim is part of the permission, not a courtesy.
  • For machinery used by non-professional users, the essential safety information stays on paper in every case — including where consumer use is merely reasonably foreseeable.
  • Medical devices are the precedent. Implementing Regulation (EU) 2021/2226 initially allowed electronic instructions for a short list of device categories; the amendment (EU) 2025/1234 of 25 June 2025, in force since 16 July 2025, deleted that list. Electronic instructions are now possible for practically all professional-use devices, with paper still available on request.
  • Omnibus IV turns the exception into the rule. The provisional agreement of 9 June 2026 amends around 20 product acts towards “digital by default”: digital declaration of conformity, digital instructions, a mandatory electronic contact point. Formal adoption was still pending at the time of writing.
  • Safety markings on the product remain physical. The Toy Safety Regulation (EU) 2025/2509 sets minimum sizes for warnings — a pictogram of at least 10 mm, x-height of 1.2 mm, or 0.9 mm for small toys — while at the same time replacing the declaration of conformity with a product passport.
  • The real effort is not the switch, it is the operation: ten years of availability, every language version, every revision, every serial-number variant — and a link that does not break when the website is relaunched.

Treating the manual as marketing material underestimates it. In product law it is part of conformity: a product whose safe use is only possible with instructions is not compliant without them. The manual closes the gap between the risks that design could not eliminate and what the user needs to know.

Three consequences shape the move to digital. First, the manual is subject to market surveillance: authorities check it, and a missing or incomprehensible manual is a defect in the same way a missing guard is. Second, it is central to product liability — proving that you warned correctly is part of the defence. Third, it is language-bound: it must be available in the language or languages determined by the Member State where the product is placed on the market, in a form the intended user understands.

Digitisation removes none of that. It only moves the carrier — and adds the duty to keep that carrier working for years.

Who may already go digital

There is no single act called “digital instructions”. There is a series of sectoral permissions that all follow the same pattern, and a horizontal amendment that generalises it.

Legal actDigital instructionsCore conditionsFrom
Machinery Regulation (EU) 2023/1230yes, Article 10(7)access route on the product; printable and storable; ten years online; paper on request; safety information on paper where consumers may use it20.01.2027
Medical devices: Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234yes, almost all professional-use deviceswebsite in all target languages; paper free of charge on request; previous versions archived for ten years; documented risk assessmentsince 16.07.2025
Omnibus IV (around 20 product acts)yes, as the defaultdigital declaration of conformity; electronic contact point; data kept in the product passport where one is requiredprovisional agreement 09.06.2026
Toy Safety Regulation (EU) 2025/2509passport replaces the declaration of conformityaccess via a data carrier; available for ten years; warnings remain physical with minimum sizes01.08.2030
ESPR (EU) 2024/1781framework for the passport per product groupdata fields and carrier are set by each delegated actper product group

The pattern is identical in every row: access has to start physically on the product, content has to be portable, availability is measured in years, and the right to paper remains as a fallback. Solve those four cleanly once and you have solved them for every act at the same time.

The five conditions in detail

1. Access starts on the product

A digital manual may not merely be “findable on the internet”. The act requires a statement on the machinery — and only where that is not possible, on the packaging or in an accompanying document — showing how to reach the instructions. In practice that is a machine-readable code on the nameplate.

This is exactly where the manual obligation meets the passport: one data carrier on the nameplate can serve several destinations at once — instructions, declaration of conformity, spare-parts list, passport data. Why a 2D code is replacing the classic barcode is covered in our article on the GS1 2D code.

2. The content has to be portable

Print, download, store locally: that is a deliberate rejection of formats that tie the user to an app, a login or a live internet connection. A manual that exists only inside a web viewer does not meet the condition. A manual embedded in the machine’s own software meets it only if it can also be printed and saved from there.

It is a practical requirement too. Shop floors often have no signal, and the maintenance technician is standing in front of an installation in a basement with a tablet.

3. Availability is measured in years

The Machinery Regulation refers to the expected lifetime of the machinery and at least ten years after it was placed on the market. For medical devices, previous versions must be kept for ten years. For the toy passport, availability is ten years.

Ten years is an eternity for product documentation. In ten years a website will be relaunched at least once, a CMS swapped, a domain moved, a filename changed. Each of those events breaks a link that is engraved on a nameplate and can no longer be altered. The consequence: the code on the product must not point at a file, it must point at a stable identifier whose resolution remains changeable.

4. Languages stay mandatory — and become more visible

Digitisation does not shrink the language obligation, it makes it measurable. On paper you could work with multi-language booklet bundles; digitally, every missing language version is a click that leads nowhere. For medical devices it is explicit: the current instructions must be on the website in all relevant languages of the target markets.

Selling in 27 Member States therefore means managing not one document but a matrix of product variants, revisions and languages. That is the point where manuals stop being a document problem and become a data problem.

5. The right to paper remains

In every act mentioned here the customer can request a paper version — free of charge, and for machinery within one month of a request made at purchase. Cancelling the print run entirely therefore requires a process: who takes the request, who prints, who ships, in which language, in which revision.

In practice that means print-on-demand from the same source that generates the digital version. Two separately maintained versions will diverge — and the divergence is the defect.

What stays on paper or on the product

The most common misreading is “digital allowed” equals “no more paper at all”. Wrong. Three areas remain physical.

Safety information for consumer products. The Machinery Regulation is unambiguous: for machinery intended for non-professional users — or where such use is reasonably foreseeable — the safety information essential for commissioning and safe use must be supplied on paper in every case. The rest of the manual may be digital.

Warnings and markings on the product. The Toy Safety Regulation (EU) 2025/2509 actually tightens them while introducing the passport: warnings are preceded by the word “Warning” or a generic pictogram of at least 10 mm, with a minimum x-height of 1.2 mm — 0.9 mm for small toys. The future Omnibus IV rules likewise leave safety-relevant information on the product or in paper form untouched.

The statement of the access route itself. The code that leads to the digital manual is physical by definition. It has to stay legible after ten years in an oily environment — which is decided by material and placement in engineering, not by software.

What belongs in a manual

The legal acts say that instructions must accompany the product and list mandatory content per sector. How a good manual is built is defined by a standard: IEC/IEEE 82079-1:2019, “Preparation of information for use (instructions for use) of products”. It is published jointly by IEC, IEEE and ISO and covers everything from a tin of paint to a turnkey industrial plant.

Its practical value lies in two things. First, it treats information for use as a process rather than a document: audience analysis, information management, empirical testing of comprehensibility, competence of the authors. Second, it enforces structure — and structure is exactly what a digital manual needs if it is not to end up as a 200-page PDF in which nobody finds anything.

The minimum set that sectoral rules and the standard jointly expect:

  • identification of product, manufacturer and authorised representative, including a contact route
  • intended use and explicitly prohibited misuse
  • transport, assembly, commissioning, adjustment
  • operation, including residual risks and required protective equipment
  • maintenance, inspection intervals, spare parts
  • troubleshooting and behaviour in case of failure
  • decommissioning, dismantling, disposal
  • technical data and a reference to the declaration of conformity

Capture the manual as structured content rather than a layout file and the same building blocks feed the product passport. Maintain it as an InDesign document and you do the work twice.

How the passport carries the manual

The reason this topic is surfacing now is not the Machinery Regulation alone, it is the combination. Omnibus IV provides that where another Union act already requires a digital product passport, the information from the declaration of conformity and the electronic instructions should be kept in the passport rather than maintained in parallel. The passport stops being a sustainability artefact and becomes the access point for the entire product documentation.

For implementation that means three things.

One data carrier, several destinations. A code on the nameplate resolves to the manual, the declaration of conformity or the passport data depending on the request. The difference between a static QR code and a resolvable identifier is decisive here — we took it apart in QR code vs GS1 Digital Link.

Version binding instead of file storage. The manual belongs to a product version, not a product name. If serial number 4711 shipped with software 2.3, the matching revision must still be reachable in eight years, alongside the current one.

One source for paper and screen. The paper fallback and the digital version have to come from the same data. Anything else is a divergence that will eventually be found.

What that data layer looks like in practice is described in our article on DPP and PIM; the formal relationship between passport and declaration is covered in when the passport replaces the EU declaration of conformity.

Implementation in five steps

1. Establish the applicable act per product family

Not “may we go digital?” but “which act applies to which product, and what does it allow?”. A machine, a medical device and a toy have three different answers — and a company with a mixed portfolio needs all three.

2. Decide the physical access route

Nameplate, packaging or accompanying document; material, size and placement of the code; legibility after years in service. That decision is made in engineering, not in IT, and it cannot be changed for ten years afterwards.

3. Set up resolution and archive

Stable identifier, changeable resolution, a version archive holding every language version, an availability commitment covering ten years. This is where the real technical debt appears if you get it wrong.

4. Define the paper process

Who accepts requests, what the delivery deadline is, which source is printed from, who records fulfilment. One month is tight if the request arrives by post at the sales desk.

5. Structure the manual instead of laying it out

Break content into blocks that can be combined per variant and per language. That is the groundwork which later fills the product passport — and the point where the investment pays off. The full sequence for the passport project as a whole is in our DPP implementation checklist.

Frequently asked questions

Can I drop the paper manual entirely from 2027?

No. For machinery aimed at professional users you may ship fully digital, but you must supply paper free of charge within one month on request. For machinery that consumers may use, the essential safety information stays on paper in every case.

Is a QR code pointing to a PDF on our website enough?

Technically it satisfies “printable and storable”, but legally only for as long as the link works. Since availability has to be guaranteed for at least ten years and the code on the nameplate cannot be changed, a direct file link is the most fragile design available. A resolvable identifier is the durable route.

Do digital instructions apply to machinery sold before 2027?

The permission applies to products falling under the Machinery Regulation, that is those placed on the market from 20 January 2027. Existing stock is governed by the law in force when it was placed on the market — including its paper requirement.

What exactly does Omnibus IV change about instructions?

It generalises the permission: instead of individual sectoral rules, digital supply becomes the default in around 20 acts, with a mandatory electronic contact point and the requirement to keep the information in the product passport wherever a passport is required. At the time of writing there was a provisional agreement dated 9 June 2026; the final text may differ in detail.

Do I need dedicated software for digital instructions?

Not necessarily, but you need three functions: a stable identifier with changeable resolution, a version and language archive with a retention period, and a way to produce paper from the same source. Solving that with folder structures collapses by the third language. myDPP keeps the manual, the declaration of conformity and the passport data behind a single data carrier — see our overview.

Sources

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