The EU Machinery Regulation, from 20 January 2027

From 20 January 2027, new machinery placed on the EU market or put into service no longer follows Directive 2006/42/EC but Regulation (EU) 2023/1230. The Directive is repealed on the same date. The date in the published text was originally 14 January 2027 and was corrected by the corrigendum of 4 July 2023, so some older materials show the wrong date.

For a factory, the Regulation matters in three situations: when it buys a machine or a line, when it modifies an existing machine, and when it builds or integrates equipment for its own use. Machinery already in service does not have to be brought up to the new requirements. Its use remains governed by the rules on work equipment, in Romania Government Decision (HG) 1146/2006.

There is no period of choice

The European Commission page states clearly that machinery placed on the market before 20 January 2027 must comply with the Directive. After that date only the Regulation applies. There is no window in which the manufacturer can choose either text, so the relevant date is the one on which the machine is placed on the market or put into service, not the order date.

The practical consequence: a line ordered now, with delivery and commissioning in spring 2027, will have to come with a declaration of conformity under the Regulation. EU type-examination certificates issued under the Directive remain valid until they expire (art. 52(2)), but that does not change the text that applies to the new machine.

Substantial modification

The Directive did not define the term. The Regulation does, in art. 3(16): a modification of a machine or related product, by physical or digital means, made after it has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, which affects safety by creating a new hazard or increasing an existing risk, and which requires either the addition of guards or protective devices that make it necessary to modify the existing safety control system, or additional measures for stability or mechanical strength.

Art. 18 says that whoever makes a substantial modification is considered the manufacturer. That means conformity assessment, technical documentation, a declaration of conformity and CE marking for the modified machine. The exception in the same article covers only non-professional users who modify their own machine, so it does not apply to a factory.

Some examples of modifications that need careful checking, as working assumptions: raising the speed of an axis above what the manufacturer foresaw, adding a robot to an existing cell and changing the safety logic, replacing a safety PLC and rewriting its program, moving a machine into a line where it connects to other machines. The words “digital means” in the definition show that a software-only change can also be a substantial modification.

Integrated lines and in-house builds

The definition of machinery in art. 3(1) includes assemblies of machinery or of partly completed machinery. A line made up of several functionally linked machines, integrated by your own team, is an assembly. And art. 3(18) also treats as manufacturer anyone who puts a product into service for their own use.

If the engineering department builds a pneumatically actuated assembly fixture or integrates a cell from bought-in components, the factory has the obligations of a manufacturer: risk assessment under Annex III, technical documentation kept for at least 10 years (art. 10(3)), declaration of conformity and CE marking. The obligation existed under the Directive. What is new is that an in-house build put into service after 20 January 2027 must also meet the new requirements below.

New requirements: software and attacks

Annex III contains the essential health and safety requirements. Two points are new and bear directly on automation.

Point 1.1.9, protection against corruption, requires that connecting another device, including remotely, does not lead to a hazardous situation, that safety-critical hardware and software are protected against accidental or intentional corruption, and that the machine collects evidence of legitimate or illegitimate interventions. The machine must identify the software needed for it to operate safely.

Point 1.2.1 requires control systems to withstand foreseeable malicious attempts by third parties that would lead to a hazardous situation. It also requires a log of the data generated by an intervention and of the safety software versions uploaded, kept for five years from the upload.

For machinery with fully or partially self-evolving behaviour or logic (machine learning), the same point requires that the machine does not perform actions outside the defined task and movement space, that data on safety-related decisions is kept for one year, and that the machine can be corrected at any time.

Digital instructions

Art. 10(7) allows instructions in digital format. They must be downloadable and printable and must stay available online for the expected lifetime of the machine and at least 10 years after it is placed on the market. If the buyer asks for paper instructions at the time of purchase, the manufacturer supplies them free of charge within one month at most.

Paper instructions no longer come automatically. If you want them at the machine or for maintenance, ask for them in the contract. Keep an internal copy of the files too, and do not rely on a link alone.

The Annex I categories

Annex I lists the categories with special conformity assessment procedures. Part A requires a notified body. Besides some classic categories, it covers safety components with fully or partially self-evolving behaviour using machine learning, and machinery that incorporates them.

Part B has 19 categories, including cold metal working presses with manual loading or unloading, injection or compression moulding machines for plastics and rubber with manual loading or unloading, protective devices designed to detect the presence of persons, and logic units to ensure safety functions. For these, the manufacturer may use self-assessment (module A) only if harmonised standards covering all relevant essential requirements have been applied. Otherwise a notified body is needed (art. 25(3)).

What to do before January 2027

1. List the machines and lines to be commissioned after 20 January 2027 and check with suppliers which text they will deliver under.
2. In new contracts, state explicitly conformity with Regulation (EU) 2023/1230, the requirements in points 1.1.9 and 1.2.1, the format of the instructions and the handover of software version logs.
3. List the planned retrofits and modifications and assess each one, before the work, against the definition of substantial modification. Keep the analysis in writing.
4. Add a mandatory check to the internal technical change procedure for changes to safety software and parameters.
5. For in-house builds and integrations, decide who signs the declaration of conformity and who keeps the documentation.
6. For cells with remote access (maintenance over VPN, connection to MES), agree with IT who controls access.

What is still unclear

In January 2025 the Commission sent the European standardisation organisations a standardisation request for the Regulation (C(2025) 129), with deadlines staggered over several years. It is not clear how many harmonised standards for the new requirements, especially those on corruption and self-evolving systems, will be cited in the Official Journal by January 2027. This matters directly for the Annex I Part B categories, where self-assessment depends on standards.

The Commission page still lists the application guide for the Directive, not a guide for the Regulation. The practical interpretation of substantial modification for concrete cases will only become clear through guidance and the practice of the authorities.

Proposal COM(2025) 504 also amends Regulation 2023/1230, mainly to make the declaration of conformity digital. The agreement between Parliament and Council was confirmed in June 2026, but the plenary vote was provisionally scheduled for 23 November 2026, so the text was not yet law at the time of writing.

It is not yet clear which national act Romania will use to set the penalties and the authorities for the new Regulation. It is worth watching the Official Gazette (Monitorul Oficial) in the coming months.

If you are preparing a retrofit or a new line for 2027, put your questions in the WhatsApp group “HSE (Health, Safety & Environment)”.