Key Terms
- Machinery
- An assembly fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, joined together for a specific application [Art. 3(1)].
- Substantial modification
- A modification of machinery by physical or digital means after placing on the market, not foreseen by the manufacturer, that affects safety by creating a new hazard or increasing an existing risk [Art. 3(16)].
- Safety component
- A physical or digital component, including software, designed to fulfil a safety function, independently placed on the market, whose failure or malfunction endangers persons' safety [Art. 3(3)].
- Partly completed machinery
- An assembly that cannot in itself perform a specific application and is only intended to be incorporated into or assembled with other machinery to form a complete product [Art. 3(10)].
- EU declaration of conformity
- A document drawn up by the manufacturer stating that the applicable essential health and safety requirements of Annex III have been fulfilled, following the relevant conformity assessment procedure [Art. 21].
- Harmonised standard
- A European standard adopted on the basis of a request by the European Commission; compliance creates a presumption of conformity with the essential health and safety requirements it covers [Art. 20(1)].
- Notified body
- A conformity assessment body designated by a Member State and notified to the Commission to carry out third-party conformity assessment procedures under this Regulation [Art. 26, Art. 29].
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Frequently Asked Questions
Can I still place machinery on the market under the old Machinery Directive 2006/42/EC after 20 January 2027?
No. Directive 2006/42/EC is repealed with effect from 20 January 2027 [Art. 51(2)]. All machinery placed on the market from that date must comply with Regulation (EU) 2023/1230. However, products already placed on the market in conformity with the Directive before that date may continue to be made available [Art. 52(1)].
What is a 'substantial modification' and why does it matter?
A substantial modification is a change — physical or digital — made after a product was placed on the market or put into service, not foreseen by the manufacturer, that affects safety by creating a new hazard or increasing an existing risk, requiring additional protective measures or modification of existing ones [Art. 3(16)]. The person carrying out such a modification is treated as a manufacturer and must perform a full conformity assessment [Art. 18].
Does the Regulation apply to AI-powered machinery?
Yes. Safety components with fully or partially self-evolving behaviour using machine learning that ensure safety functions are listed in Annex I, Part A. This means they require the strictest conformity assessment: EU type-examination (module B + C) or full quality assurance (module H) by a notified body [Art. 25(2), Annex I Part A, items 5-6].
Can manufacturers provide instructions for use only in digital format?
Instructions may be provided in digital format [Art. 10(7)]. However, the instructions must be in a language easily understood by users as determined by the Member State concerned, and must be clear, understandable and legible [Art. 10(10)]. Manufacturers must provide paper instructions upon request at no additional cost for non-professional users, and the delivery details are subject to further specifications.
Are existing EC type-examination certificates still valid after 20 January 2027?
EC type-examination certificates and approval decisions issued under Article 12 of Directive 2006/42/EC remain valid until they expire [Art. 52(2)]. However, new products placed on the market from 20 January 2027 must hold conformity documentation under the new Regulation.
What penalties apply for non-compliance?
The Regulation does not set EU-wide fine amounts. Instead, Member States must lay down effective, proportionate and dissuasive penalties — which may include criminal penalties for serious infringements — and notify the Commission by 20 October 2026 [Art. 50]. Market surveillance authorities can additionally prohibit products from the market, or order withdrawal or recall [Art. 43, Art. 46].
Do importers have specific obligations under this Regulation?
Yes. Importers must verify that the manufacturer has carried out the appropriate conformity assessment, drawn up the technical documentation and affixed the CE marking. They must keep a copy of the EU declaration of conformity for at least 10 years and ensure source code for safety software is available to authorities on request [Art. 13].
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