The New Machinery Regulation Implementation Act

The New Machinery Regulation Implementation Act – National Specifications Supplementing the EU Machinery Regulation

With Regulation (EU) 2023/1230 the European regulatory framework for machinery has been comprehensively updated. The new regime was adopted on 14.06.2023 and will apply in full and directly in all Member States from 20.01.2027.

The Regulation (EU) 2023/1230 (the so-called EU Machinery Regulation, hereinafter MR) modernises the existing machinery law in a fundamental way, strengthens the digital provision of documentation, and clarifies and expands responsibilities along the supply chain. At the same time, it marks the departure from the previous Machinery Directive, aiming to more effectively reflect technological developments such as AI, connectivity, and software.

Although the MR does not generally require national transposition, a national implementation act is still necessary because the regulation leaves room for Member State provisions in key areas—such as language requirements, procedures, and sanctions.

Germany provides the necessary legal framework through the Act Implementing Regulation (EU) 2023/1230 (Maschinenverordnung-Durchführungsgesetz, hereinafter: MaschinenDG). The MaschinenDG defines competences, sets out administrative and criminal offences, regulates market surveillance mechanisms, and simultaneously repeals the previous 9th Ordinance to the Product Safety Act (Neunte Verordnung zum Produktsicherheitsgesetz, hereinafter 9. ProdSV). The Act entered into force on 06.12.2025.

The following provides an overview of key provisions of the MaschinenDG.

A. Language Requirements

The MR allows Member States to determine the mandatory language for instructions and safety information under Annex III MR (Art. 10(7), subpara. 5 MR).

Under Sec. 2(1) No. 1–3 MaschinenDG, German will be mandatory for the following documents:

  • instructions for use,
  • safety information, and
  • the EU declaration of conformity.

The same applies to assembly instructions and EU declarations of incorporation for partly completed machinery (Sec. 2(2) MaschinenDG). Distributors must ensure that all documentation is available in German.

The MR permits digital provision of instructions, provided that they can be downloaded, stored and printed, and remain available online for at least ten years (Art. 10(7) MR). The MaschinenDG further specifies these requirements: all access information to the digital instructions must likewise be provided in German (Sec. 2(1) subpara. 2; Sec. 2(2) subpara. 2 MaschinenDG).

Manufacturers, importers and distributors must therefore verify already prior to placing machinery on the market that all documents are complete and available in the German language.

B. Notification of Conformity Assessment Bodies

Chapter V MR (Art. 26 et seq.) governs the notification procedure for conformity assessment bodies (Notified Bodies).

The Central Office of the Federal States for Safety (Zentralstelle der Länder für Sicherheitstechnik, hereinafter ZLS) will continue to act as the national notifying authority under the MR. Sec. 3 MaschinenDG refers to the existing provision in Sec. 10(1) sentence 1 of the Act on Making Products Available on the Market (Produktsicherheitsgesetz, hereinafter ProdSG), according to which the competent authority holds the power to designate conformity assessment bodies.

Testing bodies must therefore submit their designation applications to the ZLS and notify any changes directly to the ZLS.

C. Market Surveillance – Sampling Benchmark and Notification Channels

Pursuant to Sec. 4(2) MaschinenDG, the nationwide sampling benchmark of 0.5 samples per 1,000 inhabitants per year applies (Sec. 25(2) ProdSG).

Market surveillance will be subject to stronger central coordination. Market surveillance authorities must notify the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, hereinafter BAuA) of any non-compliance of machinery, related products or partly completed machinery within the meaning of Art. 43(2) and (4), subpara. 2 MR (Secs. 5–7 MaschinenDG). Risks existing despite the conformity of machinery within the meaning of Art. 45 MR must likewise be reported to BAuA (Sec. 7 MaschinenDG).

If a market surveillance authority authorises the placing on the market of certain machinery under the emergency procedure provided for in Art. 25c MR (as introduced by Amending Regulation (EU) 2024/2748), it must immediately notify the European Commission and the other EU Member States via BAuA (Sec. 8 MaschinenDG).

D. Administrative Fines and Criminal Provisions

Sec. 9 MaschinenDG sets out 26 administrative offences subject to fines of up to EUR 10,000 or EUR 100,000, for instance in cases of missing CE marking or failure to carry out corrective actions. In particular, violations of labelling obligations—e.g., absence of CE marking (Sec. 9(1) No. 21 MaschinenDG)—are covered. Notably, compliance with the safety and health requirements under Annex III MR is not included among the fine provisions.

In cases of intentional, persistent violations or endangerment of life or health, imprisonment of up to one year or a fine may be imposed (Sec. 10 MaschinenDG).

The level of the fine depends on the severity of the violation.

E. Transitional and Applicability Provisions

In principle, the MaschinenDG, including the language requirements and sanction provisions, will apply from 20.01.2027 (Secs. 12–13 MaschinenDG).

Under Sec. 11 MaschinenDG, machinery placed on the market under the 9. ProdSV before 20.01.2027 may continue to be operated and marketed. However, new machinery may only be placed on the market under the new law from that date onwards. The transitional regime thus enables an orderly shift to the new framework.

Conclusion and Outlook

With the MaschinenDG, Germany establishes the necessary foundation for harmonised and digital machinery regulation under the MR.

For companies, the new provisions mean:

  • All instructions for use, safety information and EU declarations of conformity must be available in German; this also includes access information for digital instructions.
  • ZLS will continue to serve as the notifying authority for conformity assessment bodies.
  • Economic operators may face fines of up to EUR 10,000 or EUR 100,000 for violations of various obligations under the MR.
  • The key provisions relevant for companies will apply from 20.01.2027.

The time until entry into effect in 2027 should be used to adapt internal processes—manufacturers and distributors, in particular, should ensure at an early stage that their instructions, compliance processes and IT infrastructure meet the new requirements.

The MaschinenDG thus marks the next important step towards a modern and digital machinery safety framework.

Do you have any questions about this news or would you like to discuss it with the author? Please contact: Marie Carnap

9. December 2025 Marie Carnap, LL.M.