Besides instructions for use, Regulation (EU) 2023/1230 governs two other key documents: the EU declaration of conformity and the technical documentation, often called the technical file. Digital instructions are covered in digital instructions and QR codes.
The EU declaration of conformity
Its content is defined in Annex V, part A. Art. 10 states that the instructions are accompanied by the EU declaration of conformity or by an internet address or machine readable code giving access to it. It can therefore be made available digitally, with a link or a QR code.
The technical documentation
Annex IV lists what it must contain, including:
- a general description of the machine and drawings;
- the risk assessment and protective measures taken;
- the standards and technical specifications applied;
- test reports and calculations;
- a copy of the instructions for use and of the EU declaration of conformity.
The technical documentation must be kept available to market surveillance authorities for the period set by Art. 10. The official text is the source to check for each specific case.
Why manage it digitally
Technical documentation changes over time: new revisions, replaced components, updated instructions. A digital archive with versions, history and access logs helps find the valid version for each machine and show it when needed.
How Certiblok® helps
- The DRM® & Archive module stores each document with versions, history, owner, expiry and access log.
- Documents cannot be edited, only updated: previous versions remain stored and restorable.
- Every document automatically has its own QR code, public or private.
- The Audit Room creates document rooms with expiry for inspectors and auditors, with access to authorised files only.
Certiblok® is a tool that supports document management: it does not replace the manufacturer's conformity assessment.
Sources
For the full picture, go back to the Machinery Regulation guide.
