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The new Regulation (EU) 2023/1230 (known as the EU Machinery Regulation) will be directly applicable in all Member States from 20 January 2027 (for a detailed overview of the changes, please refer to our technical article ‘New Machinery Regulation’). The EU Machinery Regulation does not require national implementation. However, a national implementing law is necessary because the regulation leaves room for Member States to regulate key areas such as language requirements, procedures and sanctions.
With the draft law implementing Regulation (EU) 2023/1230 (Machinery Regulation Implementation Act, hereinafter: MaschinenDG-E), Germany is creating the necessary legal basis for this. It defines responsibilities, regulates fines and criminal offences as well as market surveillance mechanisms, and at the same time repeals the previous 9th Regulation to the Product Safety Act (9. ProdSV).
The Federal Government's draft bill was published on 8 September 2025 as BT-Drucksache 21/1507 and passed by the Bundestag on 16 October 2025. If and to the extent that the Bundesrat has no objections to the draft bill, it will come into force after being signed by the Federal President.
The key provisions of the draft MaschinenDG are examined in more detail below.
The EU Machinery Directive leaves it up to the Member States to decide on the binding language for instructions and safety information within the meaning of Annex III of the EU Machinery Directive (Art. 10(7) subparagraph 5 EU Machinery Directive).
According to § 2 (1) No. 1–3 MaschinenDG-E, German will be mandatory in future for:
The same applies to assembly instructions and EU declarations of incorporation for incomplete machinery ( § 2 (2) MaschinenDG-E). Distributors must ensure that all documents are available in German.
The EU Machinery Regulation allows instructions to be provided digitally, provided that they can be downloaded, stored and printed and are available online for at least ten years (Art. 10(7) EU Machinery Regulation).
The MaschinenDG-E also specifies these requirements: All access information for the digital instructions must also be provided in German ( § 2 (1) subparagraph 2, (2) subparagraph 2 MaschinenDG-E).
Manufacturers, importers and distributors must therefore check before placing the product on the market whether all documents are complete and available in German.
II. Notification of conformity assessment bodies
Chapter V of the EU Machinery Regulation (Art. 26 ff.) regulates the procedure for notifying conformity assessment bodies (known as Notified Bodies).
The Central Office of the German Federal States for Safety Technology (ZLS) will continue to act as the national notifying authority under the new EU Machinery Regulation. Section 3 of the draft Machinery Act refers in this respect to the existing provisions of Section 10(1) sentence 1 of the Product Safety Act (ProdSG), according to which the competent authority is responsible for designating conformity assessment bodies.
Testing facilities must therefore submit their applications for designation to the ZLS and notify the ZLS immediately of any changes.
III. Market surveillance – sampling reference value and reporting channels
According to § 4 (2) of the MaschinenDG-E, the nationwide sampling guideline value of 0.5 samples per 1,000 inhabitants per year (§ 25 (2) ProdSG) will apply in future.
Market surveillance will be subject to greater central coordination. Market surveillance authorities must report the non-conformity of a machine, an associated product or an incomplete machine within the meaning of Art. 43 (2) and (4) sentence 2 of the EU Machinery Regulation to the Federal Institute for Occupational Safety and Health (BAuA) ( §§ 5–7 MaschinenDG-E). Risks that exist despite the conformity of the machinery pursuant to Art. 45 EU Machinery Regulation are also reported to the BAuA by the market surveillance authorities, § 7 MaschinenDG-E.
If the market surveillance authority approves the placing on the market of certain machinery in accordance with the emergency procedure provided for in Art. 25c Machinery Regulation (within the meaning of Amendment Regulation (EU) 2024/ 2748) to place certain machinery on the market, it must immediately inform the European Commission and the other Member States of the European Union via the Federal Institute for Occupational Safety and Health ( § 8 MaschinenDG-E).
§ 9 MaschinenDG-E contains 26 administrative offences with fines of up to EUR 10,000 or EUR 100,000, for example in the case of missing CE marking or failure to take corrective measures. These include, in particular, violations of labelling requirements, e.g. in the case of missing CE marking (Section 9 (1) No. 21 MaschinenDG-E). It is interesting to note that compliance with the safety and health protection requirements set out in Annex III of the Machinery Regulation is not covered.
In the event of intentional, persistent violations or a hazard to life and health, imprisonment of up to one year or a fine may be imposed (Section 10 MaschinenDG-E).
The specific amount of the fine depends on the severity of the violation.
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Essentially, the MaschinenDG-E, including the language requirements and sanction standards, will apply from 20 January 2027 ( §§ 12 f. MaschinenDG-E).
According to § 11 MaschinenDG-E, machines that were placed on the market before 20 January 2027 in accordance with the 9th ProdSV may continue to be operated and marketed. However, from this date onwards, new machines may only be placed on the market in accordance with the new law. The transition phase thus enables an orderly changeover.
VI. Conclusion and prospects
The MaschinenDG-E lays the foundation for harmonised and digital machine regulation in Germany.
For companies, the new regulations mean that:
There is still time to adapt internal processes before the 2027 deadline, but this time should be used wisely. Manufacturers and distributors in particular should ensure at an early stage that their operating instructions, compliance processes and IT infrastructures comply with the new requirements.
The MaschinenDG-E thus marks the next important step towards modern and digital machine safety regulation.
You can open the full text of the Machinery Regulation Implementation Act (in German) via the following link:
Machinery Regulation Implementation Act from 08 September 2025
Posted on: 2025-11-10
Marie Carnap, LL.M., is a lawyer at the Produktkanzlei. She specialises in advising on product compliance issues and advises international and national manufacturers, importers and distributors of non-food products (consumer and investment goods) on product safety and product liability law.
E-Mail: carnap@produktkanzlei.com
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