EU Machinery Regulation (Regulation (EU) 2023/1230): machinery and related products, including safety components with self-evolving behaviour
Machinery and related products sold in the EU must meet essential health and safety requirements, with third-party conformity assessment for the higher-risk categories in Annex I Part A, which the recitals say should include safety systems with self-evolving behaviour using machine learning. Manufacturers must keep a complaints register, take corrective action at once and inform national authorities when a product presents a risk.
Scope. Reaches a US maker of machinery, robots or safety components sold in the EU: its EU importer may place only compliant products on the market and must check that the manufacturer has drawn up the technical documentation (Article 13(1)-(2)).
Draft mapping. Drafted by the Register's agents from the rule's text and not yet confirmed by a person. It is the Register's reading, not legal advice: whether and how the rule applies to you is a question for counsel.
Controls this rule maps to
Required by the text The rule's text requires a measure that is this control, or plainly includes it. Implied A binding rule whose purpose needs this control, but whose text does not name it. The Register's reading. Recommended A voluntary standard or guidance recommends it; nothing binds you to it. Proposed Appears in a proposed rule or proposed provision that is not yet in force.
| Control | Strength | Where in the rule, and why | Confidence | Missing or failed in |
|---|---|---|---|---|
| Organizational recovery process C-R4 | Required by the text | Article 10(9): manufacturers who have reason to believe a product is not in conformity 'shall immediately take the corrective actions necessary to bring that machinery or related product into conformity, to withdraw it or to recall it' and, where it presents a risk, 'shall immediately inform the competent national authorities'; Article 10(4): 'If necessary, manufacturers shall keep a register of complaints' (conditional). | high | 1 case |
| Independent assurance before deployment C-O2 | Required by the text | Article 25(2): for categories in Annex I Part A the manufacturer 'shall apply' EU type-examination (module B+C), full quality assurance (module H) or unit verification (module G), each with a notified body; Annex I Part A point 5: 'Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions' and point 6: machinery with such embedded systems. Limited to those categories. | high | 1 case |
| Physical safety interlock C-E4 | Required by the text | Article 10(1) with Annex III 1.2.4.3: 'The machinery or related product shall be fitted with one or more emergency stop devices to enable actual or impending danger to be averted' (exceptions where it would not lessen the risk, and hand-held machinery); 1.2.4.1: a control device to bring the machinery 'safely to a complete stop'. | high | 1 case |
| Containment and isolation C-E5 | Implied | Annex III 1.1.9 (Protection against corruption): 'the connection to it of another device ... does not lead to a hazardous situation' and critical software and data 'shall be adequately protected against accidental or intentional corruption'; 1.2.1(a): control systems withstand 'reasonably foreseeable malicious attempts from third parties'; Article 20(9) presumption of conformity via a cybersecurity certification scheme. Isolation is the usual means but is not named. | medium | 7 cases |
| Hard domain restriction C-E2 | Required by the text | Annex III 1.2.1: control systems with fully or partially self-evolving behaviour designed to operate with varying levels of autonomy 'shall not cause the machinery or related product to perform actions beyond its defined task and movement space'. | high | 4 cases |
| Kill switch faster than the actor C-X2 | Required by the text | Annex III 1.2.4.3: the emergency stop device shall 'stop the hazardous process as quickly as possible'; 'The emergency stop function shall be available and operational at all times, regardless of the operating mode'; 1.2.1: 'the machinery or related product shall not be prevented from stopping if the stop command has already been given'. | high | 2 cases |
| Independent audit log C-V1 | Implied | Annex III 1.1.9: 'The machinery or related product shall collect evidence of a legitimate or illegitimate intervention in the software or a modification of the software installed'; 1.2.1 (autonomous control systems) point (b): recording of data on the safety-related decision-making process is enabled and 'retained for one year after its collection'. The text does not require the record to be beyond the system's reach. | high | 1 case |