Machinery Regulation FAQ Software Updates

Review a software update before deployment when it touches software or data that is critical to meeting essential health and safety requirements. Regulation (EU) 2023/1230 expressly treats safety components as physical or digital components, including software, and recognises machinery that is missing only the upload of application-specific software.

Escalate the release if it changes a safety function, safety-related control-system logic, operating parameters, limits generated during a learning phase, remote connectivity, configuration rules, safety logs, or the instructions users rely on to keep the machinery safe throughout its lifetime.

Annex III requires software and data critical for conformity with essential health and safety requirements to be identified and protected against accidental or intentional corruption. It also requires machinery to identify the software needed for safe operation and provide that information in an easily accessible form.

A release process should therefore preserve more than release notes. It should show which safety software changed, who authorised it, how corruption protection was tested, and whether the machinery collects evidence of legitimate or illegitimate intervention in relevant hardware, software, or configuration.

The Regulation defines substantial modification as a post-market or post-service modification by physical or digital means that was not foreseen or planned by the manufacturer, affects safety by creating a new hazard or increasing an existing risk, and requires specified protective changes. Software updates should be screened against that definition before release to customers or fielded equipment.

Even when the update does not meet the substantial-modification threshold, the manufacturer still needs procedures so series production remains in conformity and must account for changes in design, characteristics, harmonised standards, technical specifications, or common specifications used to declare conformity.

Software updates can make existing instructions wrong. Article 10 and Annex III require instructions to describe the corresponding product model, intended use, precautions, safe installation and use, residual risks, protective measures, maintenance, breakdown response, and other safety information. Digital instructions are allowed, but access, download, print, lifetime availability, and paper-on-request requirements still matter.

Keep the CE file aligned with the release. Technical documentation should make conformity assessable and include an adequate risk analysis and assessment; manufacturers must keep technical documentation and the EU declaration of conformity available to market surveillance authorities for at least 10 years after placing on the market or putting into service. Where relevant and necessary for checking Annex III compliance, source code or programming logic included in technical documentation must be made available to competent national authorities on reasoned request.