Regulation (EU) 2023/1230 generally applies from 20 January 2027, not 2026. Its AI-related conformity rules target specified self-evolving machine-learning safety components and embedded systems, rather than every collaborative robot. Manufacturers must assess the applicable category, control-system requirements and transition rules before treating a cobot as subject to third-party assessment.
When does Machinery Regulation 2023/1230 apply?
The corrected Article 54 sets general application for 20 January 2027, with specified provisions applying earlier; it does not establish the original article’s January 2023 certification deadline.
EU-OSHA explains that the regulation replaces Directive 2006/42/EC and sets essential health and safety requirements for machinery placed on the European market, with technical details mainly supplied through harmonised standards.
The regulation addresses manufacturers and other economic operators, including importers, and applies directly in Member States without national transposition.
EU-OSHA identifies technical documentation, the applicable conformity assessment, the EU declaration of conformity and CE marking among manufacturers’ responsibilities.
Does every AI-enabled cobot require third-party assessment?
No: Annex I Part A targets particular safety components and embedded systems with fully or partially self-evolving behaviour using machine learning to ensure safety functions, not every robot merely described as collaborative or AI-enabled.
For the embedded-system category in Annex I Part A, point 6, the provision concerns systems not independently placed on the market and applies only in respect of those systems.
Recital 55 distinguishes these self-evolving safety systems from software incapable of learning or evolving and programmed only to execute automated functions.
Which conformity-assessment routes apply?
For Annex I Part A categories, Article 25(2) requires one of three routes involving a notified body: EU type-examination followed by conformity to type, full quality assurance, or unit verification.
| Category or distinction | Legal scope | Conformity consequence |
|---|---|---|
| Annex I Part A, point 5 | Self-evolving machine-learning safety components | Article 25(2): B plus C, H, or G |
| Annex I Part A, point 6 | Specified embedded self-evolving safety systems not independently placed on the market | Article 25(2), in respect only of those systems |
| Annex I Part B | Categories listed separately from Part A | Internal production control only if the Article 25(3) standards or common-specifications conditions are met |
| Fixed automation software | Software incapable of learning or evolving | Recital 55 excludes it from the specified self-evolving-software provisions; other applicable duties still require assessment |
What safety records must learning systems retain?
Annex III, section 1.2.1 requires relevant autonomous, fully or partially self-evolving control systems to enable recording of safety-related decision-making data for software-based safety systems and retain that data for one year after collection.
That retention provision is expressly for demonstrating conformity in response to a reasoned request from a competent national authority, rather than a universal requirement to buy continuous third-party audits for every cobot.
A separate provision in section 1.2.1 requires tracing logs for intervention data and uploaded safety-software versions to be enabled for five years after upload, for the stated conformity-demonstration purpose.
Annex III, section 1.1.9 also requires safety-critical software and data to be identified and protected against accidental or intentional corruption, with evidence collected of interventions or modifications.
Does the regulation require a 200 ms human override?
Annex III requires the relevant self-evolving machinery to remain correctable at all times to maintain inherent safety; section 1.2.4.3 requires emergency stops, subject to its exceptions, to halt the hazardous process as quickly as possible without creating additional risks.
Those provisions do not specify the original article’s blanket 200 ms limit for force-limiting functions.
Section 1.2.1 requires manufacturers to establish safety-function limits in the risk assessment and prevent learning-phase changes that could lead to hazardous situations.
Must existing cobots be replaced or recertified?
Article 52 protects further making available of products placed on the market in conformity with Directive 2006/42/EC before 20 January 2027 and keeps existing EC type-examination certificates and approval decisions valid until they expire.
Under Article 18, a person carrying out a substantial modification generally takes on manufacturer obligations and must apply the relevant conformity-assessment procedure, subject to the article’s exception for non-professional users modifying machinery for their own use.
Article 3(16) limits substantial modification to unplanned physical or digital changes affecting safety through a new hazard or increased risk and requiring the specified additional guards, protective devices or protective measures.
What does the regulation say about penalties?
Article 50 leaves penalty rules to Member States and requires them to be effective, proportionate and dissuasive; it does not set the original article’s EU-wide maximum of €5 million or 10% of annual revenue.
Member States must notify the Commission of those rules by 20 October 2026, a date distinct from the regulation’s general application on 20 January 2027.
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