The Machinery Regulation (EU 2023/1230) is the EU legislation governing the safety of machinery, interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices, and partly completed machinery. It entered into force in June 2023 and applies from 14 January 2027, replacing the Machinery Directive (2006/42/EC) which it repeals on the same date.
What It Covers
The Machinery Regulation applies to:
- Machinery — an assembly of linked parts or components, at least one of which moves, with appropriate actuators, control and power circuits, joined together for a specific application
- Safety components — components that serve a safety function, whose failure endangers the safety of persons
- Interchangeable equipment — devices which modify the function of a machine and are placed on the market for assembly by the operator
- Partly completed machinery — an assembly that is almost machinery but cannot in isolation perform a specific application (requires integration)
Notably excluded: domestic household appliances, certain vehicles, watercraft, certain agricultural tractors, weapons, nuclear installations, and equipment governed by other directives (hoists in mines, medical devices, marine equipment).
Key Changes from the Machinery Directive (2006/42/EC)
The 2023 Regulation introduces several significant updates:
| Topic | Machinery Directive (2006/42/EC) | Machinery Regulation (EU 2023/1230) |
|---|---|---|
| Digital systems | Limited provisions | Explicit requirements for software and firmware reliability, cybersecurity of machinery control systems |
| AI and autonomous functions | Not addressed | New essential requirements for machinery with AI-enabled autonomous behaviour |
| Partly completed machinery | Declaration of Incorporation only | Stricter traceability and documentation requirements |
| Conformity assessment | Annex IV products → NB required | Expanded Annex I with updated mandatory NB scope |
| Transitional period | — | Until 13 January 2027, Machinery Directive still valid; from 14 January 2027, only the Regulation applies |
Essential Health and Safety Requirements (EHSRs)
The Regulation specifies Essential Health and Safety Requirements in Annex III. Manufacturers must identify which EHSRs apply to their specific machinery and demonstrate compliance through design, protective measures, and user information. Key categories:
- General principles — risk assessment and risk reduction (hierarchy: design out → guard → inform)
- Control systems — reliability, safe failure behaviour (relates to EN ISO 13849-1 / IEC 62061 for functional safety)
- Protection against mechanical hazards — guards, interlocks, stability
- Required characteristics of guards and protective devices
- Risks from other hazards — electrical, thermal, noise, radiation, materials/substances
- Maintenance — designed for safe maintenance
- Information and marking — CE marking, nameplate, operating instruction requirements
Conformity Assessment
For most machinery, Module A (internal production control) applies — the manufacturer self-declares conformity, compiling the Technical File and Declaration of Conformity.
For machinery and safety components listed in Annex I (the most dangerous types), a Notified Body must perform EU Type Examination (Module B) before the declaration can be issued. Examples of Annex I machinery include:
- Woodworking machines with fixed blade
- Presses with hand or foot operation
- Safety components for machinery (sensing floors, light curtains, two-hand control devices)
- Industrial robots designed for use with humans
Functional Safety and EN ISO 13849-1
For safety-related control systems within machinery, the Machinery Regulation’s essential requirements link directly to the functional safety standards:
- EN ISO 13849-1 — defines Performance Levels (PLa to PLe) for safety functions implemented in control systems
- IEC 62061 — defines Safety Integrity Levels (SIL 1 to SIL 3) for E/E/PE safety-related systems
Embedded control systems within machinery must be designed and validated to achieve the required Performance Level or SIL for each safety function — a hardware and software design discipline distinct from standard product development.
Official References
- Regulation (EU) 2023/1230 (Machinery Regulation) — Full text — EUR-Lex, Official Journal of the European Union