2023年7月4日
New Machinery Regulation: the most important changes and what companies need to do
The time has come: the European Machinery Regulation Regulation (EU) 2023/1230 ("Machinery Regulation") has been published in the Official Journal of the European Union. The Machinery Regulation replaces the long-standing Machinery Directive 2006/42/EC ("Machinery Directive") and thus is of utmost importance for companies that handle "machinery" in any form: through manufacturing, importing, distributing or any other way of operating.
The scope of application is far-reaching, see for example the definition of machinery in Art. 3 para. 1 of the Machinery Regulation, but also the "related products", Art. 2 para. 1 of the Machinery Regulation. The legal coverage of machinery is currently at its peak. From 30 recitals and 29 articles, machinery law has grown to 86 recitals and 54 articles. The major revolution, however, has failed to materialize. Many of the particularly intensive amendments of the first draft of 21 April 2021 (COM (2021) 202 final) have been either removed again or at least significantly diminished. This article presents a selection of the most important amendments to the Machinery Regulation to provide an initial overview of the innovations.
Date of application of the Machinery Regulation:
The Machinery Regulation enters into force on 19th July 2023 and will be applicable from 20 January 2027, i.e. 42 months after the entry into force, Art. 54 of the Machinery Regulation. All parties concerned – in particular manufacturers, importers, authorized representatives, distributors and operators – have therefore time to prepare for the new rules. However, the new rules must be fully complied with by 20 January 2027. This means that companies should start considering the new requirements well in advance of the deadline, as it takes time to prepare the documentation and certifications required by the new regulations.
Welcome to the New Legislative Framework:
The Machinery Regulation is structured according to the New Legislative Framework (“NLF”). As is well known from European product compliance, all economic operators now have allocated responsibilities. One of the practically "most visible" effects: machinery importers must now be labelled with their name and address.
Regulation instead of Directive:
Due to its legal nature, the Machinery Regulation is directly applicable in all EU member states without the need for national implementation. We expect that the current national implementation of the Machinery Directive in Germany, the 9th ProdSV, to become more of a torso. In the future, it will most likely only contain market surveillance responsibilities, criminal provisions and administrative offences.
Specified scope of application:
The new Machinery Regulation explicitly covers machinery, related products and partly completed machinery, Art. 2 of the Machinery Regulation. The European legislator is attempting to eliminate previous ambiguities regarding the scope of the preceding Machinery Directive with other harmonized legal acts, in particular with the Low Voltage Directive and the Radio Equipment Directive. For example, Art. 2 para. 2 lit. p of the Machinery Regulation clarifies that the scope of the Machinery Regulation does not apply to electrical and electronic products specifically defined in the Regulation, insofar as they are subject to the Low Voltage Directive or the Radio Equipment Directive.
New Annex numbering:
The Machinery Regulation has rearranged the annexes. However, the familiar topics remain covered therein as shown in this overview:
| Topic | So far regulated in | In future regulated in |
|---|---|---|
| Essential health and safety requirements |
Annex I Machinery Directive | Annex III Machinery Regulation |
| Declaration of conformity and incorporation | Annex II Machinery Directive | Annex V Machinery Regulation |
| CE marking | Annex III Machinery Directive | Separate annex omitted, requirements in Article 23 f. Machinery Regulation |
| Machines that can potentially pose a particular risk | Annex IV Machinery Directive | Annex I Machinery Regulation, now divided into Parts A and B |
| Safety components - indicative list | Annex V Machinery Directive | Annex II Machinery Regulation |
| Assembly instructions for partly completed machines | Annex VI Machinery Directive | Annex XI Machinery Regulation |
| Technical documentation | Annex VII Machinery Directive | Annex IV Machinery Regulation |
| Conformity assessment procedure | Annexes VIII to X Machinery Directive | Annexes VI to X Machinery Regulation |
| Requirements relating to notified bodies | Annex XI Machinery Directive | Separate Annex omitted, now in Article 30 Machinery Regulation |
Definition of "substantial modification":
The Machinery Regulation codifies the term "substantial modification" in Art. 3 No. 16. Anyone who makes a "substantial modification" to a machinery is considered a manufacturer and must therefore fulfill all obligations associated with this role, in particular needs to carry out a new conformity assessment. This obligation is in principle limited to the modified part of the machinery. The situation is, however, different if the modification concerns the machinery as a whole, see Art. 18 and Recital 26 of the Machinery Regulation. In future, companies will see themselves more quickly confronted with a substantial modification because the requirements changed: contrary to the Interpretation paper of the Federal Ministry of Labour and Social Affairs from 2015, a substantial modification will also exist if the machinery can be returned to a safe condition by a "simple protective device".
Digital machinery law:
- The digital instructions for use
Manufacturers can now digitize their instructions for use. They remain, however, obliged to ensure that distributors can provide the user of the machinery with a printed version of the instructions free of charge when purchasing the machinery (cf. recital 40). If the manufacturer opts for digital instructions, he must (i) indicate on the machinery how the instructions can be accessed and (ii) provide the instructions in a "printable format" (PDF), Art. 10 para. 7 of the Machinery Regulation. - Artificial Intelligence
The draft AI Regulation has been decoupled from the Machinery Regulation. Special requirements now apply to machineries/machinery parts that "have embedded systems with fully or partially self-evolving behaviour using machine learning approaches", see Annex I Part A No. 6 of the Machinery Regulation. It remains to be seen when we can speak of "self-evolving behaviour". The Machinery Regulation further defines requirements for protection against interference and for the resilience of control systems, see Annex III Part B Sec. 1.1.6 lit. f), Sec. 1.2.1 subpara. 2 lit. d), 1.2.1 subpara. 3 of the Machinery Regulation. - Cybersecurity
Another digitalization component of the Machinery Regulation is its cybersecurity requirements. Manufacturers must take appropriate measures (now explicitly required by law) to ensure the security of their machinery against potential cyber threats and protection against interference. This includes the implementation of security measures to prevent accidental or intentional corruption, manipulation or theft of data, cf. Annex III Sec. 1.1.9, Sec. 1.2.1 of the Machinery Regulation.
Modified procedures for machinery subject to specific conformity assessment procedures:
The term "high-risk machinery" was not included in the Machinery Regulation. The intention was to avoid stigmatizing such machinery. The bottom line is that the machines in Annex IV of the Machinery Directive are now – with some additions – listed in Annex I of the Machinery Regulation. If the machines are listed in Part A of Annex I of the Machinery Regulation (e.g. machineries whose safety functions are provided by the system with "self-evolving behaviour"), one of the following, more comprehensive conformity assessment procedures, must be applied: either (i) EU type-examination followed by conformity to type based on internal production control, (ii) unit verification or (iii) full quality assurance, Art. 25 para. 2 of the Machinery Regulation.
For machinery listed in Annex I Part B of the Machinery Regulation, the same conformity assessment obligations apply if the manufacturer has not designed and built it entirely in accordance with the relevant harmonized standards or common specifications, Art. 25 para. 3 of the Machinery Regulation. This is already established in Art.12 para. 4 of the Machinery Regulation.
After-market obligations for manufacturers:
In line with the implementation of the NLF, the new Machinery Regulation now also explicitly provides for after-market obligations for manufacturers. Art. 10 para. 9 of the Machinery Regulation explicitly states that manufacturers must "immediately take the corrective actions necessary" to ensure their conformity with the Regulation. This includes notifying the competent national authorities and withdrawing or recalling the products concerned.
Conclusion:
The great revolution in machinery law has indeed failed to materialize. The devil, though, is in the details. The new Machinery Regulation comes with a number of important changes that apply immediately from 20 January 2027. Required documents and certificates cost effort and money and therefore need to be prepared in advance – preferably now.
