The current Machinery Directive 2006/42/EC will be replaced by the Machinery Regulation (EU) 2023/1230. The Regulation was published in the Official Journal on 29 June 2023, entered into force on 19 July 2023, and will apply to placing machinery on the market from 20 January 2027. pilz.com+2EUR-Lex+2
Until 19 January 2027, new machinery can still be placed on the EU market under the Machinery Directive. From 20 January 2027, only the Machinery Regulation applies; several authorities explicitly describe this as a key-date regime without a transitional phase in which both instruments can be used alternatively. DGUV+2compliance.globalnorm.de+2
1. Directive vs Regulation – formal change
- The Machinery Directive is implemented via national legislation; the new Machinery Regulation is directly applicable in all Member States, which should lead to a more uniform interpretation. EUR-Lex+1
- The concept of “machinery” is broadened to “machinery products”, explicitly including certain related products and safety components. EUR-Lex+1
National laws will still regulate enforcement, market surveillance and sanctions, but the technical requirements themselves are now laid down in a single EU text.
2. Main substantive changes
a) High-risk machinery products (Annex I, Part A)
The former Annex-IV list of the Directive reappears in the Regulation as “potentially high-risk machinery products” in Annex I Part A. Maschinenrichtlinie+1
For these categories the Regulation always requires independent assessment by a notified body; self-certification based only on a harmonised standard is no longer sufficient. Maschinenrichtlinie+1
This especially affects machinery where AI or complex software performs safety-related functions. Home of Welding+1
b) Digitalisation, industrial security, software
The Regulation explicitly brings digital topics into machinery law:
- Safety-related control functions must be protected against corruption or manipulation, i.e. cyber-security becomes part of the safety concept. EUR-Lex+2osha.europa.eu+2
- There are new rules for handling software updates and vulnerabilities. EUR-Lex+1
- Digital instructions for use are expressly permitted. Users may, however, demand a paper manual free of charge, which must then be supplied within a set period (usually one month). adt-zielke.com+2tekom.de+2
Purely software-based or digital components that perform safety functions can now count as safety components in their own right. EUR-Lex+1
c) Substantial modification
For the first time, the Regulation gives a legal definition of “substantial modification” in Article 3(16). In summary, it is: Waves Engineering+2Certification Experts+2
- a physical or digital modification of a machinery product that
- takes place after it has been placed on the market or put into service,
- is not foreseen or planned by the original manufacturer, and
- affects safety by creating new hazards or increasing existing risks, such that additional protective measures are required.
Anyone who makes such a substantial modification becomes the manufacturer of the modified machine and must carry out a new conformity assessment under the Machinery Regulation (at least for the modified part, and for the whole machine if the modification affects it as a whole). Taylor Wessing+2produktkanzlei.com+2
Typical maintenance and repair activities are generally not regarded as substantial modifications, provided they restore the original safety level without introducing new hazards. FME+1
3. Practical consequences for manufacturers and operators
For manufacturers
- Portfolio review: identify which products fall under Annex I Part A and will therefore always require a notified body. Maschinenrichtlinie+1
- Adapt CE processes:
- risk assessment (still based on ISO 12100) must be extended to cover new digital and cyber risks,
- safety-related control systems (e.g. EN ISO 13849-1) and documentation have to reflect the Regulation’s terminology and structure. pilz.com+1
- Project planning: new or fundamentally redesigned machinery with a planned market launch from 2027 onwards should already be designed to comply with the Machinery Regulation rather than only the Directive. BAuA+1
For operators and retrofit projects
- Major changes to controls, drives or protective measures can qualify as a substantial modification; in that case the operator effectively becomes the manufacturer of the modified machine, with full responsibility under the Regulation. Waves Engineering+2Certification Experts+2
- Retrofit projects should be planned so that they satisfy both the current national requirements for work equipment and the future Machinery Regulation requirements from 2027. Guidance from authorities such as BAuA and national market-surveillance bodies already emphasises this forward-looking approach. BAuA+1
4. How I support companies
In practice I support manufacturers, operators and retrofit teams with:
- Risk assessments and PLr determination according to EN ISO 12100 and EN ISO 13849-1,
- review and adaptation of CE procedures and technical files to align with the Machinery Regulation,
- assessment of whether a planned retrofit is a substantial modification and what that implies for conformity assessment,
- compact workshops on the new requirements (high-risk machinery, digital manuals, cyber-security, AI, substantial modification).