What changes when (EU) 2023/1230 replaces the Machinery Directive on 20 January

The Machinery Regulation (EU) 2023/1230 sets the EU's rules for how machinery must be designed and built. It replaces the Machinery Directive 2006/42/EC and applies to machinery placed on the market or put into service from 20 January 2027.

A regulation applies directly in every member state, with the same text everywhere. The directive had to be transposed into each country's law, in Sweden through the regulations of the Swedish Work Environment Authority (Arbetsmiljöverket). With the regulation, the differences between countries disappear.

The regulation entered into force on 19 July 2023. Manufacturers were given three and a half years to adapt, and some provisions, including those on notified bodies, applied earlier.

The regulation covers machinery and a few related products, listed in Article 2 and defined in Article 3:

• Machinery, including assemblies of machinery such as a robot cell or a production line.
• Interchangeable equipment, which changes the function of a machine.
• Safety components, which now include standalone software that performs a safety function.
• Lifting accessories, and chains, ropes and webbing.
• Removable mechanical transmission devices.
• Partly completed machinery, such as an industrial robot to be built into a cell.

Article 2(2) lists what falls outside it, including certain means of transport, equipment for military use and several kinds of electrical product covered by the Low Voltage Directive.

• Substantial modification is defined in Article 3(16), and anyone who substantially modifies a machine counts as its manufacturer under Article 18.
• Annex I replaces Annex IV of the directive and splits higher-risk machinery into two parts. Part A always requires a notified body. For Part B, internal production control is enough if harmonised standards or common specifications cover every requirement that applies to the machine (Article 25).
• Annex III has new and revised essential health and safety requirements, including protection against corruption (1.1.9), safety and reliability of control systems (1.2.1) and requirements for machinery with self-evolving behaviour.
• The technical file must also describe how production is controlled and include the safety-related software (Annex IV, Part A, points (h) and (m)).
• Instructions for use may be digital under the conditions in Article 10(7), and the EU declaration of conformity may also be supplied digitally.
• The Commission can adopt common specifications where harmonised standards are lacking (Article 20).
• Importers and distributors get their own, explicit obligations.

A machine placed on the market under the directive before 20 January 2027 does not need to be CE marked again when the regulation applies. How it is used at the workplace is governed by other rules, in Sweden by Arbetsmiljöverket's regulations on work equipment.

If you rebuild a machine, you need to decide whether the change is substantial. If it is, you take on the manufacturer's obligations for whatever the change affects: risk assessment, technical file, EU declaration of conformity and CE marking.

Under Article 3(16), a substantial modification is a physical or digital modification that the manufacturer did not foresee and that affects safety by creating a new hazard or increasing an existing risk. The modification must also call for new guards or protective devices that in turn require changes to the control system's safety functions, or for new protective measures for the machine's stability or mechanical strength.

So not every change is substantial. Swapping in an equivalent component, or a change the manufacturer planned for, usually is not. Assess each change on its own, and record the assessment even when the answer is no.

• Find out which machines will be placed on the market or put into service after 20 January 2027, including those being designed now.
• Check whether any machine, or part of one, falls under Annex I.
• Draw up the list of essential requirements against Annex III of the regulation instead of Annex I of the directive.
• Follow which standards are published under the regulation. Presumption of conformity comes from harmonised standards whose references have been published under the regulation in the Official Journal of the EU.
• Update your templates for the EU declaration of conformity, the instructions for use and the technical file.
• Keep the safety-related software for every version you deliver.
• Decide how you assess and document rebuilds.

Every machine in Verkio has the legislation that applies to it, the regulation or the directive. For existing and modified machines, the assistant helps you decide which, and whether a change could count as substantial.

The assistant has the full text of both acts and cites the article or annex it relies on, so you can read the text yourselves. The technical file checklist follows Annex IV of the regulation and Annex VII of the directive.

The judgement is yours. Verkio never certifies that a machine meets the requirements.