Chapter 3. Gap Assessment

Identify what needs to change in your designs, risk assessments, and documentation

Compliance with the old Machinery Directive does not equal compliance with the new Machinery Regulation. This assessment helps you understand whether you have identified, and are acting on, the specific gaps introduced by the expanded Essential Health and Safety Requirements in Annex III.

Country

Your name

Company

Q1. Are you aware that the new Machinery Regulation introduces mandatory cybersecurity requirements (Annex III, 1.1.9) that did not exist under the old Machinery Directive 2006/42/EC?

Q2. Do you know that Annex III now requires machinery to resist both accidental and intentional software corruption, and to log all interventions for traceability?

Q3. Have you updated your risk assessment methodology since July 2023 to explicitly include cybersecurity threats, AI/software failures, and autonomous behaviour as hazard categories?

Q4. Do you have documented technical controls protecting safety-related software from unauthorised modification, corruption, or remote manipulation?

Q.5 Have you conducted a formal comparison (gap analysis) between your existing product documentation/technical files and the requirements of Annex III of the Machinery Regulation?

Q6. Which best describes your current exposure to the new cybersecurity requirements?