Machinery Regulation: What changes on 20 January 2027

On 20 January 2027, the Machinery Directive 2006/42/EC will be replaced by Regulation (EU) 2023/1230 (Art. 51(2), Art. 54). A regulation applies directly in every Member State and does not need to be transposed into national law, which means that the same text applies to manufacturers throughout the EU. The Regulation contains new requirements regarding software, protection against external interference and subsequent modifications.

This article is a technical classification of the text of the Regulation and does not constitute legal advice.

The cut-off date

The Regulation applies from 20 January 2027. At the same time, the Machinery Directive 2006/42/EC is repealed (Art. 51(2), Art. 54). There is no transition period in which manufacturers can choose between the old and the new law.

Every unit delivered counts

Which rules apply to a machine depends on when it is placed on the market, i.e. when a specific unit is made available on the market for the first time (Art. 3(12)). When the machine was developed plays no role. A series machine of proven design that is delivered on 21 January 2027 must therefore comply with the new Regulation, even if it was developed in 2025 and has been built unchanged ever since.

Machinery placed on the market in accordance with the Directive before the cut-off date may continue to be made available on the market (Art. 52(1)). EC type-examination certificates issued under the Directive remain valid until they expire (Art. 52(2)).

Software as part of safety

The Regulation makes clear that safety components can also be digital, including software (Art. 3(3)). This results in requirements for the control system, which must be protected against foreseeable malicious attempts to interfere with it. Hardware through which safety-relevant software can be accessed must be protected against corruption and must make any interference traceable. Interventions in the safety software and all versions of this software must also be recordable (Annex III, 1.1.9 and 1.2.1).

From a technical point of view, remote access, maintenance interfaces and software updates must therefore be assessed as possible hazards in the risk assessment and addressed by appropriate measures. A safety function that depends on software is judged by how well it is protected against manipulation and to what extent an intervention can be proven afterwards.

When a notified body is required

Whether a manufacturer may assess conformity itself or must involve a notified body depends on Annex I. Safety components and embedded systems with self-evolving behaviour, i.e. machine learning, that perform safety functions are listed in Annex I, Part A. For these, the Regulation requires a conformity assessment by a third party, either by means of EU type-examination, full quality assurance or unit verification (Annex I, Part A, points 5 and 6, Art. 25(2)).

For the categories of machinery listed in Annex I, Part B, internal production control is only permitted if harmonised standards or common specifications cover all relevant requirements and have been applied in full. If this is not the case, a notified body must be involved (Art. 25(3)). Machinery that is not listed in Annex I remains subject to internal production control (Art. 25(4)). Because involving a notified body takes time, the classification of each machine type determines when you need to contact such a body.

Substantial modification and manufacturer obligations

The Regulation defines a substantial modification as a physical or digital modification made after the machine has been placed on the market. Substantial means that the modification was not foreseen by the manufacturer and affects safety by creating a new hazard or increasing an existing risk. As a result, new guards with changes to the safety-related control system or additional measures to ensure stability or strength become necessary (Art. 3(16)). Anyone who carries out such a modification takes on all the obligations of a manufacturer, including the conformity assessment (Art. 18).

This also affects operators who convert their installations and service providers who carry out retrofits. Because the definition explicitly includes digital modifications, it also applies to software updates and functions added later.

Instructions for use and declarations of conformity in digital form

The instructions for use may only be provided in digital form if certain conditions are met (Art. 10(7)). The machine or its packaging must state how the instructions for use can be accessed. They must be printable and storable and must remain available online for the entire lifetime of the machine and for at least ten years. If a buyer requests a paper copy at the time of purchase, it must be provided free of charge within one month. For non-professional users, the safety information must be supplied with the machine in paper form. The EU declaration of conformity may likewise be made accessible via a web address or a machine-readable code (Art. 10(8)).

Retention and source code

The technical documentation and the declaration of conformity must be kept for at least ten years (Art. 10(3)). On a reasoned request from an authority, the source code or programming logic must also be made available where this is necessary to check compliance with the requirements (Art. 11(2), (3) and (7)). For partly completed machinery, the EU declaration of incorporation and the assembly instructions remain the relevant documents. The software version of a delivered machine must therefore remain traceable and verifiable years later.

How to tell whether you need to take action

From a technical point of view, you need to take action if at least one of the following points applies to your product range:

• Machines from your current product range are delivered for the first time on or after 20 January 2027.
• The control system contains safety-relevant software, or this software can be accessed via interfaces.
• A safety function is based on machine learning.
• A machine falls under Annex I, and it is unclear whether harmonised standards cover all requirements.
• You or your customers make modifications to machines after delivery or change their software.
• The instructions for use exist only in paper form, or the documentation and software versions are not currently archived for long enough.

What manufacturers have to check before the cut-off date

For each machine type, the manufacturer has to compare the risk assessment with each essential health and safety requirement in Annex III. Particular attention must be paid to the control system and the software: protection against corruption and interference, the logging of interventions and software versions, and machine learning in safety functions. It must also be clarified whether the machine falls under Part A or Part B of Annex I and thus whether internal production control is sufficient or a notified body has to be involved. Finally, the instructions for use and the documentation must be checked with regard to the required content, digital provision and archiving for ten years. The longest lead times arise when a notified body has to be involved or when the control system or the software has to be redesigned and reassessed. You can find more information on conformity assessment in our article on CE marking.

IDEA takes on these tasks for you. We check the technical documentation of a machine or machine type against the Regulation and the relevant standards and show you which measures are required before the cut-off date. We can then also implement the measures. If you would like to know where your machines stand and whether action is needed, please get in touch. You will find everything else in our offer MVO-GO!.

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Sources

1. Regulation (EU) 2023/1230 – on machinery (Machinery Regulation), of 14 June 2023; consolidated version including the corrigenda of 4 July 2023 (dates) and of 1 April 2025 (German language version). All article references in this article refer to this version.
2. Directive 2006/42/EC – on machinery (Machinery Directive), of 17 May 2006; repealed with effect from 20 January 2027.