High-Risk Machinery
"High-Risk Machinery" is the industry term for equipment categories listed in Annex I of the new Machinery Regulation (formerly Annex IV of the Machinery Directive). These machines are singled out because a failure could result in catastrophic injury or death. The new regulation splits this list into two distinct parts, fundamentally changing how North American manufacturers must approach certification.
Annex I, Part A contains six categories of "super high-risk" equipment, including vehicle servicing lifts and safety components with self-evolving AI behavior. For these, Self-Certification is banned; you must undergo certification by a Notified Body.
Annex I, Part B includes traditional heavy machinery like industrial presses, circular saws, and injection molding machines. For these, you have a choice: you can self-certify (Module A) only if you fully apply relevant Harmonized Standards. If you deviate from these standards—or if none exist—you are forced to hire a Notified Body for a Type Examination.
