Regulations
Digital instructions for use: Guide 2.3 and the Machinery Regulation
What changes for the provision of the instructions for use in digital format and how to manage machine documentation.
Version 2.3 of the Guide to the Application of the Machinery Directive has anticipated an irreversible trend: the documentation of the machines can be handled more digitally, provided the user always has access to the information necessary for the safe use of the product.
The Regulation (EU) 2023/1230 consolidates this evolution, providing instructions in digital format under precise conditions. For manufacturers, digitization can reduce costs, improve up-to-dateness and make document management more efficient, but must be designed by method.
Why Guide 2.3 is important
The Machinery Directive Guide is not a technical standard and does not replace the legislative text, but represents a very useful interpretative reference for the uniform application of the requirements of the Directive. Version 2.3 has introduced important clarifications on the instructions for use and the declaration of conformity in digital format. Reference
Digital instructions for use: Opportunities and Limits
A digital instructions for use must not become an obstacle to access to information. If the operator fails to consult it during a failure, maintenance or critical phase, the document system is not adequate. The key point is to ensure availability, readability, download, print and light link between instructions for use and machine model.
Practical rules to provide digital instructions
- Define a stable document platform, controlled by the manufacturer and not dependent on the machine software only.
- Create a clear document encoding: model, freshman or family, language, revision and date.
- Insert the access method to the instructions on the machine or in the accompanying documents.
- Allow printing and downloading of the document.
- Manage revisions and storage, avoiding unstable links or untracked documents.
Digital Compliance Statement
The declaration of conformity can also be digitally managed, but must remain accessible, identifiable and connected to the correct product. For the manufacturer it is essential to avoid generic copies, unstable links or non-consistent declarations with the model and configuration of the machine.
What manufacturers need to do
Digitization must be designed as part of the compliance system, not as a simple publication of an online PDF. instructions for use, declarations, technical files, revisions management and after-sales assistance must be consistent. Reference
- update instructions for use template and statement;
- define internal rules for publication and storage;
- Validate QR code, URL and offline/print availability;
- maintain consistency with risk analysis and EN ISO 20607; Reference
- provide clear instructions for the request of the paper copy.
How Waves Engineering supports manufacturers
Waves Engineering helps manufacturers to draft compliant instructions for use, digitize technical documentation, set access systems via QR code and update documents to the transition to Machinery Regulation (EU) 2023/1230. Reference
FAQ
Can a machine's instructions for use be just digital?
Yes, in the cases and under the conditions provided, but must be guaranteed access, download, print and free paper copy when required or necessary.
Just put a PDF on the site?
No. It needs a stable system, tracked and clearly connected to the machine model and document review.
Can the declaration of conformity be digital?
Yes, but it must remain accessible, identifiable and consistent with the specific product.
