The Machinery Regulation is a regulation, not a directive: it applies directly in every member state and is not rewritten into national law. The safety requirements are largely the same, but the documentation, the responsibilities along the supply chain and the treatment of software and connectivity are new. Anyone who designs, rebuilds or imports machinery needs to start early — technical documentation written today has to hold after 2027 as well. What is new, what counts as a substantial modification and how to prepare is gathered in Verkio's guide to the new Machinery Regulation 2027.
20 January 2027
From that day a machine may only be placed on the market under the Machinery Regulation. There is no transition period for new machines: what counts is the date the machine is placed on the market, not when the design began.
What is new compared with the Machinery Directive
- Machines with self-evolving behaviour and machine learning get requirements of their own — the risk assessment has to cover what the machine can learn, not only what it does on delivery.
- Cyber security becomes a safety matter: control systems must be protected against deliberate interference from outside.
- The list of high-risk machinery is reworked, and some of it needs a notified body even when harmonised standards are followed.
- Instructions may be supplied digitally, but a paper version must be available free of charge if the buyer asks for it at the time of purchase.
- The responsibilities of importers and distributors are written out rather than implied.
- Substantial modification is defined in the text, so anyone rebuilding a machine can see where the line runs.
Rebuild a machine and you become its manufacturer
A substantial modification makes it a new machine in practice: a new risk assessment, new technical documentation and a new EU declaration of conformity with your name on it. The same goes for assembling several machines into one line. After 2027 that modification is judged against the Machinery Regulation, even if the original machine was CE marked under the directive.
Common questions about the Machinery Regulation
What designers, maintenance and purchasing ask us most often ahead of 2027.
- When does the Machinery Regulation apply?
- On 20 January 2027. It entered into force back in 2023 but is not applied until then. Until that date Machinery Directive 2006/42/EC applies.
- Do we have to re-mark machines we already have?
- No. A machine lawfully placed on the market before 20 January 2027 may continue to be used as it is. Only when you modify it substantially does it have to be assessed again — against the rules in force at the time of the modification.
- What is the difference between the directive and the regulation?
- A directive is implemented country by country; a regulation applies word for word across the EU. In substance the new parts are software and self-evolving behaviour, cyber security in control systems, digital instructions, a reworked high-risk list and clearer duties for importers and distributors.
- We buy machines, we don't build them. Does this concern us?
- Yes. As a buyer you are responsible for what you bring in being marked and documented correctly, and importing from outside the EU makes you the manufacturer. Requirements are easier to put in the purchase agreement than to fix on delivery.
Not sure what applies to your machines?
Describe the machine briefly and we will say which course fits and what you need to document.
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