Regulations
Digital instructions for use under Machinery Regulation (EU) 2023/1230
New on instructions for use, digital format and contained in Machinery Regulation (EU) 2023/1230.
Regulation (EU) 2023/1230 introduces an important change for manufacturers: the ability to provide instructions for use in digital format. It is an important change, because it enables you to reduce paper, simplify document updates and make the management of the correct information more efficient.
This possibility, however, does not mean that the instructions for use can be replaced by a simple generic link or an unmanaged QR code. The digital format is only allowed if the manufacturer ensures accessibility, conservation, availability, printability and free paper copy in the cases provided.
What changes with regard to the Machinery Directive
In Directive 2006/42/EC, the instructions for use format theme has traditionally been handled with great caution, especially for safety information. The Machinery Regulation updates the framework and explicitly recognizes the possibility of digital instructions, consistent with the technological evolution of products and document processes.
From 20 January 2027, when the Regulation will be applicable and Directive 2006/42/EC will be repealed, manufacturers will be able to set a more structured digital management. However, the transition must be designed now, because it requires procedures, document infrastructure, control of the versions and clear indications for the customer.
When the instructions for use can be digital
The instructions for use can be provided in digital format when the manufacturer meets the requirements of the Regulation and ensures that the user can actually access the information. The central point is the availability of instructions when they serve: installation, commissioning, use, maintenance, regulation, troubleshooting and emergency management.
Conditions to comply
Digital instructions must be made available so that the user can access, download, save and print them. They must remain available for a suitable period and compatible with the expected useful life of the machine, as required by the Regulation. It is also necessary to indicate clearly how to access the documentation.
- simple and direct access to instructions;
- possibility to download and print the document;
- online availability for the period required;
- clear identification of the machine, model, version and applicable instructions for use;
- language comprehensible to the user according to the rules of the Member State of destination;
- procedure to request paper copy, when required.
Paper copy on request
The Regulation provides that, under certain conditions, the user can request a free paper copy of the instructions. For this reason the manufacturer must prepare a clear channel for the request, such as an email address or a dedicated page, and an internal procedure to avoid the request in a traceable way.
For machines intended for non-professional users, or when safety requires it, special attention should be paid to the availability of safety information even in a physical format or otherwise immediately accessible to the product or with it.
QR code, document portal and traceability
An efficient solution can be the use of QR code connected to a document portal controlled by the manufacturer. The QR code can be placed on the tag, on the machine or in the accompanying documentation. However, it must aim at a stable, managed and secure resource that keeps the documentation available over time.
- Define a document/version encoding system connected to model and serial machine.
- Establish where instructions for use and EU declarations of conformity will be kept.
- Ensure download, print and access without unnecessary barriers.
- Maintain historical versions and traceability of revisions.
- Predict a process for paper copy requests and updates.
What to write in the instructions for use
The digital format does not reduce the required content. The instructions for use must continue to contain all the necessary information for intended use, transport, installation, commissioning, use, maintenance, residual risks, PPE, spare parts, noise emission and safety at all stages of life. EN ISO 20607 remains a technical reference useful to structure clear and readable information.
Frequently Errors
upload an online PDF without control version
use QR code not connected to a stable page
do not predict paper copy on request
do not guarantee print and download
do not identify the instructions for use applicable to the specific machine
scan only the layout, without improving structure, clarity and usability.
How Waves Engineering supports manufacturers
Waves Engineering supports manufacturers in the editing and digitization of instructions for use according to EN ISO 20607 and Machinery Regulation. We can help define structure, content, risk management, digital document system, QR code, declarations and internal procedures for document preservation.
FAQ
Can the instructions for use be digital only from 2027?
The Regulation allows the digital format, but does not eliminate the conditions to be respected or the possibility of free paper copying when required.
Is the QR code enough to comply?
No. The QR code is just a means of access. It requires a stable, accessible, downloadable, printable and traceable document system.
Does digitalization change the contents of the instructions for use?
No. The requested content remains complete. Changes the delivery format, not the manufacturer's responsibility for the quality of information.
