Machinery Regulation 2023/1230: Key Changes for Manufacturers

When does the Machinery Regulation apply?

Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces the Machinery Directive, Directive 2006/42/EC. The deciding factor is the date each individual unit is placed on the market. Placing on the market is the first time a product is made available on the EU market, and it happens once for each unit.

In practice, a machine placed on the market on 19 January 2027 can follow the Directive. An identical machine placed on the market one day later must follow the Regulation. Units already on the market before that date can still be sold by distributors afterwards. If you have sold a model for years, every new unit from 20 January 2027 must meet the Regulation.

The machinery rules also use the idea of putting into service: the first use of a product in the EU by its end user. This matters when there is no placing on the market, for example when a company builds a machine for its own use. The machine must still comply before it is put into service.

One structural change makes life simpler. A directive must be transposed into the national law of each Member State. A regulation applies directly, with the same text everywhere. The text you read in the Official Journal is the text that applies.

Which machines need a notified body under Annex I?

Under the Directive, the starting question is whether a machine appears in Annex IV. Under the Regulation, machinery is sorted into three groups: Annex I Part A, Annex I Part B, and all other machinery. The Regulation uses the conformity assessment modules of Decision No 768/2008/EC.

Part A includes, for example, vehicle servicing lifts, and safety components or machinery with fully or partially self-evolving behaviour using machine learning, where that behaviour ensures safety functions. Many categories from the old Annex IV now sit in Part B. However, Annex I of the Regulation is not a copy of Annex IV of the Directive. Compare your product with the new descriptions word by word, and do not assume your result stays the same.

Notifications of bodies under the new Regulation are being added to NANDO, the European Commission's database of notified bodies. If you need one, check the current list early. Our guide do I need a notified body explains how to check a body's scope.

For the large majority of machines, the procedure stays close to the internal check of the Directive. The manufacturer does the assessment alone and signs the EU Declaration of Conformity.

What changes for safety software and cybersecurity?

Even if your procedure does not change, your technical file will need updating, because the essential requirements of the Regulation are not identical to those of the Directive. Two changes stand out.

• Safety software. Software that performs a safety function and is placed on the market on its own becomes a safety component. The Regulation also adds requirements on safety-related software.
• Protection against corruption. Protection of the control system against corruption becomes an essential requirement. This is treated as a safety matter.

Other EU laws apply alongside. The Cyber Resilience Act (CRA), Regulation (EU) 2024/2847, does not replace the machinery law; the two apply together. The CRA asks for cybersecurity as such: secure design, vulnerability handling and updates. Its reporting obligations apply from 11 September 2026 and its main obligations from 11 December 2027. See our guide to Cyber Resilience Act dates.

The AI Act, Regulation (EU) 2024/1689, classifies as high-risk an AI system that is a safety component of a product covered by certain product laws, including machinery, when that product needs a third-party conformity assessment. Those obligations are currently scheduled to apply from August 2027, and the EU has discussed adjusting some dates, so check the latest position.

Partly completed machinery under the Regulation

Partly completed machinery is an assembly that is almost a machine but cannot perform a specific application on its own. A drive system or a robot arm without its tooling are typical cases. It is intended to be built into a machine by someone else.

The Regulation keeps the approach of the Directive. Partly completed machinery does not carry the CE marking under the machinery law, and no notified body is involved. The manufacturer provides a declaration of incorporation and assembly instructions, and keeps the relevant technical documentation available. Once the assembly is built into the final machine, the manufacturer of that machine carries out the conformity assessment of the whole and affixes the CE marking.

Digital instructions and other documentation changes

The Regulation allows instructions in digital form, under conditions. In short:

• the user must be able to find, download and print them
• they must stay accessible for a defined period
• if the user asks at the time of purchase, a paper copy must be provided free of charge
• when the machine is intended for, or may be used by, non-professional users, the essential safety information must also be supplied on paper

Check the exact conditions in the Regulation before you remove the printed manual. Instructions must still be in a language end users in the country of sale can easily understand.

Other documents change too. Annex IV of the Regulation sets out the technical documentation, with a list very similar to Annex VII of the Directive. The Regulation has its own content for the declaration of conformity and allows more flexibility in how it is provided: either a copy with the machine or, under conditions, an internet address where it can be found. The marking on the machine must include an electronic contact, such as a website or email, alongside the postal address. Our guide to the EU declaration of conformity covers declaration content in more detail.

How to prepare before 20 January 2027

If your machines will be shipped around that date, plan their conformity assessment under the Regulation now. A practical sequence:

1. Check each machine against Annex I, Part A and Part B, and record the result.
2. If a notified body is needed, check NANDO for bodies notified under the Regulation.
3. Review the risk assessment against the new essential requirements, including safety-related software and protection against corruption.
4. Update the technical file to the structure of Annex IV of the Regulation.
5. Prepare a new declaration of conformity citing Regulation (EU) 2023/1230, and update the nameplate and instructions.
6. Keep the date of placing on the market in your records for every unit.

Some points do not change. Electrical hazards of the machine remain covered by the machinery law, so there is no separate Low Voltage Directive assessment. The Regulation keeps a similar exclusion for electrical products covered by the Low Voltage Directive, such as household appliances. Harmonised standards such as EN ISO 12100 and EN 60204-1 remain central, but check which editions are cited under the Regulation. Before you update your templates, read the Regulation directly and check the latest guidance from the Commission, because practice is still developing. Our Machinery Regulation course walks through the changes, and CE Marking Fundamentals covers the wider CE route.

Key points

• Regulation (EU) 2023/1230 applies to each machine placed on the market from 20 January 2027.
• Annex I Part A always needs a notified body; Part B needs one unless harmonised standards or common specifications are fully applied.
• Most machinery still uses module A, but the essential requirements have changed.
• Safety software placed on the market on its own becomes a safety component, and protection against corruption is an essential requirement.
• Digital instructions are allowed under conditions, including a free paper copy on request.