Machinery Regulation FAQ Cybersecurity evidence

The evidence should start with the Machinery Regulation safety question: could a connected device, remote communication path, software change, data change, or control-system logic failure create a hazardous situation? If yes, the cybersecurity record belongs inside the machinery risk assessment and technical documentation, not only in a separate IT security file.

Annex III section 1.1.9 requires protection against corruption for safety-critical signal or data hardware, software, and data. It also requires the machinery or related product to identify software necessary for safe operation and to collect evidence of legitimate or illegitimate interventions in relevant hardware, software, installed software, or configuration.

Annex III section 1.2.1 requires control systems to be designed and constructed so hazardous situations do not arise. For cybersecurity, the key evidence is not a generic penetration-test label; it is the link between foreseeable interference and the safety function that could fail.

The record should cover hardware faults, logic errors, human error, external influences, and reasonably foreseeable malicious attempts from third parties where those attempts could lead to a hazardous situation. For uploaded safety software, the Regulation also calls for a tracing log of intervention data and safety-software versions after placing on the market or putting into service.

Use standards evidence carefully. A harmonised standard can support presumption of conformity only for the essential requirements it covers, and the Machinery Regulation also allows cybersecurity certificates or statements under an EU cybersecurity certification scheme to support Annex III sections 1.1.9 and 1.2.1 only to the extent their covered requirements match those sections.

ISO/TR 22100-4 is useful context because it is machinery-specific guidance for considering IT-security threats that can influence machinery safety. It should not be presented as a complete legal answer by itself; the evidence file still needs the product-specific Annex III mapping, risk assessment, test results, software identification, intervention logs, and standards coverage analysis.

Avoid evidence that cannot be traced to a safety function or Annex III requirement. General IT policy, cloud security documentation, supplier marketing material, or a product-wide cybersecurity badge is weak if it does not show how corruption, software changes, data changes, or malicious attempts were assessed for the specific machinery configuration.