Today, 29 June 2023, the Official Journal of the European Union (OJEU) published the final text of the new Machinery Regulation. The new Regulation defines the essential health and safety requirements for machinery sold in the European Union, aiming to increase trust in new technologies, reduce administrative burdens, and strengthen market surveillance and legal certainty.
The new Regulation will apply from 20 January 2027 – with some exceptions. The original date of application was 14 January 2027, which was updated with a corrigendum published on 4 July 2023.
New EU goals and rules for machinery and robots
Overall, the new Machinery Regulation addresses certain aspects that the Current Directive, Directive 2006/42/EC, does not focus on. Consequently, the Machinery Regulation, Regulation (EU) 2023/1230 (with Corrigendum published on 4 July 2023), has six main objectives:
- Cover risks related to digital emerging technologies
- Ensure clear interpretation of scope and definition and improve safety for traditional technologies
- Reassess the classification of high-risk machinery and their conformity paths
- Reduce paper documentation
- Guarantee legal certainty
- Reduce divergences in interpretation derived from transposition
Among the main changes, the new rules introduce additional safety requirements for autonomous machines, human-machine collaboration and the safe use of Artificial Intelligence (AI) systems. The introduction of rules for AI systems used in machinery is the main innovation of this Regulation in addressing new technologies.
Transition from the Directive to the Regulation
Article 52 of the Machinery Regulation addresses the transitional provisions from the current Directive to the future Regulation. This allows manufacturers to continue placing Directive-compliant products on the market until 20 January 2027. Most importantly, certificates issued under the Directive remain valid under the Regulation until the certificate’s expiry date.
On the other hand, market surveillance authorities can act as foreseen by the Regulation already from 19 July 2023, particularly in relation to risky or non-compliant products.
Conformity paths based on product’s category
The conformity assessment of machinery changes based on the product’s category. The categories of products are listed in Annex I. For low-risk machinery, the manufacturer can self-assess under their sole responsibility that the machinery complies with the applicable law. On the contrary, products that belong to higher-risk categories require the involvement of a third-party conformity assessment body, the notified body.
Annexes VI to X define the different conformity assessments to which a product category is subject.
Authorised representative for machinery manufacturers
Machinery manufacturers can appoint an authorised representative, whether based in the EU or not. In particular, non-EU manufacturers have an obligation to have an EU-based economic operator in the Union under the Market Surveillance Regulation. This applies under the current Machinery Directive and then under the Machinery Regulation.
The authorised representative for a machinery manufacturer has at least the following tasks:
- Keep the technical documentation and the EU Declaration of Conformity
- Provide the competent authorities with the necessary information and documentation to demonstrate the product’s compliance
- Collaborate with the competent authorities to mitigate or eliminate any risks related to that product
Appointing a professional authorised representative has, however, important advantages that significantly impact your presence on the EU market.
PRODlaw Library of Documents includes an extensive section dedicated to the Machinery Directive and Regulation.
EUR-Lex (2023) Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC. Retrieved on 29/06/2023.
European Commission (2021) Proposal for a Regulation of the European Parliament and of the Council on machinery products – Executive summary of Impact Assessment. Retrieved on 29/06/2023.