Machinery Regulation (EU) 2023/1230: what applies to operators and manufacturers from 20 January 2027
From 20 January 2027, the EU Machinery Regulation replaces the Machinery Directive. What companies in Germany need to consider when buying machinery, modifying it and running existing machines – and which duties under the BetrSichV remain.
Last updated on 7 min readAMS Go editorial team
Key points at a glance
- The Machinery Regulation (EU) 2023/1230 applies directly in all EU member states from 20 January 2027 and replaces the Machinery Directive 2006/42/EC; the German Ninth Ordinance on the Product Safety Act (9. ProdSV) expires at the end of 19 January 2027.
- Machinery placed on the market under the Machinery Directive before 20 January 2027 may still be made available and operated – what counts is the date it was placed on the market (Article 52).
- Anyone who substantially modifies a machine is considered the manufacturer under Article 18 and takes on the manufacturer's obligations, from conformity assessment to CE marking.
- Instructions for use may be supplied digitally, but on request at the time of purchase they must also be provided on paper free of charge within one month (Article 10(7)); operator duties under the Ordinance on Industrial Safety and Health remain unchanged.
What is the Machinery Regulation?
The Machinery Regulation (EU) 2023/1230 sets out the safety requirements machinery must meet before it is placed on the market or put into service in the EU. It applies from 20 January 2027 and replaces the Machinery Directive 2006/42/EC, which is repealed on the same day (Article 51).
Unlike the directive, the regulation applies directly in every member state. Germany's previous transposition, the Ninth Ordinance on the Product Safety Act (9. ProdSV), expires at the end of 19 January 2027. Supplementary national rules – for example on the language of documents, market surveillance and fines – are laid down in the Machinery Regulation Implementation Act (Maschinenverordnung-Durchführungsgesetz, MaschinenDG) of 2 December 2025.
Timeline: what applies when?
Date 19 July 2023
What happensThe regulation enters into force (published in the EU Official Journal on 29 June 2023)
Date 20 January 2024
What happensThe provisions on notified bodies (Articles 26 to 42) apply
Date 6 December 2025
What happensThe MaschinenDG enters into force; its core provisions apply from 20 January 2027
Date 19 January 2027
What happensThe 9. ProdSV expires at the end of the day
Date 20 January 2027
What happensThe regulation applies in full, the Machinery Directive is repealed
What changes for operators
As an operator, you buy and use machinery. The regulation is addressed to manufacturers, importers and distributors, but it changes what you receive on delivery and what you should look out for:
- Conformity: new machinery still carries the CE marking, but the EU declaration of conformity refers to Regulation (EU) 2023/1230 instead of Directive 2006/42/EC.
- Declaration of conformity: it is supplied with the machine or can be accessed via a web address or machine-readable code stated in the instructions (Article 10(8)).
- Digital instructions: they must be downloadable, printable and storable and remain available online for at least ten years after the machine is placed on the market. The manufacturer must supply a paper version if you request it at the time of purchase – free of charge and within one month (Article 10(7)).
- Language: in Germany, instructions, safety information and the declaration of conformity must be in German (Section 2 MaschinenDG).
- Existing machinery: the regulation does not require retrofitting. For operation, the rules that applied when the machine was made available on the market are decisive (Section 5(3) of the Ordinance on Industrial Safety and Health, BetrSichV).
Modifications: when does the operator become the manufacturer?
For the first time, machinery law contains a binding definition of substantial modification (Article 3(16)): a physical or digital modification after placing on the market that the manufacturer neither foresaw nor planned, and that creates a new hazard or increases an existing risk. In addition, it must require extra guards or protective devices that involve modifying the safety control system, or extra measures to ensure stability or mechanical strength.
Anyone who substantially modifies a machine is considered the manufacturer under Article 18 – including a company that rebuilds its own plant or changes its safety software. The obligations relate to the modified machine; if, according to the risk assessment, the modification affects only one machine in an assembly, they are limited to that machine. How to check a planned modification:
- 1
Did the manufacturer foresee the change?
If the change is described in the instructions or offered as an option by the manufacturer, it is not a substantial modification.
- 2
Does it create a new hazard or increase a risk?
New functions, more power, higher speed or changed software can create new hazards.
- 3
Are the existing protective measures sufficient?
If extra protective devices involving the safety control system, or measures for stability and strength, are needed, it is a substantial modification.
- 4
Fulfil the manufacturer's obligations
Risk assessment, technical documentation, conformity assessment under Article 25, EU declaration of conformity, CE marking and updated instructions.
Independently of this, Section 10(5) BetrSichV requires employers to assess, for every change to work equipment, whether it is a change requiring inspection and whether manufacturer obligations apply. After such a change, a person qualified to carry out inspections (zur Prüfung befähigte Person) must inspect the equipment before it is next used (Section 14(3) BetrSichV).
What changes for manufacturers
High-risk machinery
New in the regulationAnnex I divides it into Part A (6 categories, always with a notified body) and Part B (19 categories, internal production control only if harmonised standards or common specifications are applied in full)
Protection against corruption
New in the regulationConnecting other devices or remote access must not lead to hazardous situations; interventions in safety-relevant software must be traceable (Annex III point 1.1.9)
Self-evolving behaviour
New in the regulationSafety components and systems using machine learning that perform safety functions are listed in Annex I Part A; control systems must not act beyond defined tasks and movement spaces (point 1.2.1)
Autonomous mobile machinery
New in the regulationSpecific requirements, including a supervisory function that allows a supervisor to stop the machine remotely (point 3.2.4)
Documentation
New in the regulationDigital instructions permitted, declaration of conformity via link or code; keep technical documentation for at least ten years (Article 10)
A manufacturer is also anyone who builds a machine for their own use and puts it into service (Article 3(18)). Machinery built in-house is therefore subject to the same requirements as purchased machinery.
What stays the same: operator duties under the BetrSichV
The Machinery Regulation governs placing on the market; the Ordinance on Industrial Safety and Health governs use at work. That does not change – and CE marking does not replace your own risk assessment (Gefährdungsbeurteilung) (Section 3(1) BetrSichV).
- Risk assessment before use, ideally before selection and purchase; review it regularly, taking the state of the art into account (Section 3)
- Only provide work equipment that is suitable for the work and safe (Section 5)
- Organise maintenance safely and assess changes (Section 10)
- Provide operating instructions and instruct employees before first use and at least once a year (Section 12)
- Inspections by qualified persons – before first use where safety depends on installation, at regular intervals and after changes requiring inspection (Section 14)
Checklist for operators
- Current and planned machinery orders with delivery from January 2027 checked for conformity with Regulation (EU) 2023/1230
- Purchasing rules set: German documents, declaration of conformity, request a paper copy of the instructions at the time of purchase where needed
- Digital instructions and declarations of conformity downloaded and filed on receipt of goods
- Risk assessment for new machinery completed before first use
- Planned modifications and software changes checked for substantial modification
- Manufacturer obligations fulfilled or outsourced to a service provider in case of substantial modification
- Changes requiring inspection identified and inspection arranged before use
- Operating instructions and safety briefings adapted to new or modified machinery
Free templates for this guide
As PDF and Excel, free – to use in your own company.
Frequently asked questions
When does the new Machinery Regulation apply?
Regulation (EU) 2023/1230 applies from 20 January 2027. From that day the Machinery Directive 2006/42/EC is repealed, and the German 9. ProdSV has expired at the end of 19 January 2027. Some provisions, for example on notified bodies, have applied since 20 January 2024.
Does existing machinery have to be adapted to the Machinery Regulation?
No. Machinery placed on the market under the Machinery Directive before 20 January 2027 may still be made available and operated. As an operator in Germany, however, you must ensure under the Ordinance on Industrial Safety and Health that it is safe, review the risk assessment regularly and take the state of the art into account.
Are paper instructions still mandatory?
Not automatically. Manufacturers may provide the instructions digitally. If you request a paper version at the time of purchase, the manufacturer must supply it free of charge within one month. If a machine is intended for non-professional users or can foreseeably be used by them, the essential safety information must be supplied on paper.
When is a modification a substantial modification?
When the change was not foreseen by the manufacturer, creates a new hazard or increases a risk, and therefore requires extra protective devices involving the safety control system or measures for stability and strength (Article 3(16)). This can also be a software change. Anyone who makes such a modification is considered the manufacturer.
Terms from the glossary
This guide gives a general overview of German occupational safety law and does not replace legal advice. The regulations in force and the rules of the statutory accident insurance institutions are authoritative.
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