EU Machinery Regulation 2023 – here we go

2023-01-04 In mid-December 2022, the EU Parliament and Council agreed on the core of a new EU Machinery Regulation 2023. The new, provisionally agreed regulations are now awaiting a first reading opinion from the EU Parliament. If things proceed as usual, the new Machinery Products Regulation should have met all formal requirements in the EU Parliament by mid-2023.

42 months to go until EU Machinery Regulation

The EU Machinery Regulation 2023 will apply 42 months after its entry into force, replacing the 2006 Machinery Directive, so presumably economic operators will have to apply the new regulation from late 2026 or early 2027.

Conformity assessment by manufacturers

The agreement reached by Parliament and the Council provides for six categories of machinery to be included in Annex I.

Manufacturers and all other economic operators (online traders, distributors, importers/importers, authorized representatives, etc.) may continue to place only machinery on the EU market that complies with the essential health and safety requirements. The machinery products must undergo a conformity assessment procedure.

For certain products, the manufacturer may perform a conformity assessment himself. This applies to products listed in Annex I, Part B.Special conformity assessment

Special conformity assessment

Annex I Part A lists products that are subject to more stringent conformity assessment procedures. The procedures must be carried out by third parties (notified body). This applies, for example, to some machines with specific AI. The criteria for a classification of the machine products for a special conformity assessment are exactly defined. The EU Commission adapts the classification according to the state of the art.

State of the art in Annex I

Ask us. We regularly check for changes in the list for risk machines in Annex I of the new EU Machinery Regulation.

Significant modification

Pleasing especially for manufacturers and operators: the new term “substantial modification”. The new regulation clearly defines when a machine has been substantially modified within the meaning of the regulation and thus has to undergo the conformity assessment procedure for CE marking again as a new machine.

Digital operating instructions perhaps standard

Digital operating instructions are still under discussion. EU MEPs seem to give preference to the introduction of digital-only documents over paper-based solutions. The final version of the EU Machinery Regulation will probably provide final legal clarity here.

EU Machinery Directive to be applied directly in 2023

The previous Machinery Directive 2006/42/EC was implemented in the EU member states in separate legislative processes. In contrast, the new regulation is directly applicable in all EU countries – and can thus achieve greater legal clarity and uniform interpretation and implementation of the requirements.

Background to the EU Machinery Regulation 2023

On 21.04.2021, the EU Commission presented a proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on machinery products. This was done as part of the Artificial Intelligence package and the aim to modernize the legal framework for machinery and close gaps on product safety legislation in the Machinery Directive.

Note

The IMCO Rapporteur, Ivan Štefanec (EPP), announced on 12/15/2022 that the IMCO Committee had reached agreement on the revision of the Machinery Directive. Mr. Štefanec will report on the final trilogue (negotiators from the EU Parliament and Council) at the IMCO Committee meeting on January 23-24, 2023.

Further information

See our article EU Machinery Regulation instead of Machinery Directive. EU-Maschinenverordnung statt Maschinenrichtlinie.

Info on the draft and EU agreement on the EU Machinery Regulation 2023 on 15.12.2022 can be found here.

https://www.europarl.europa.eu/committees/en/regulation-on-machinery-products/product-details/20220906CDT10121

https://www.europarl.europa.eu/news/en/press-room/20221212IPR64522/safety-of-machinery-deal-on-updated-rules-fit-for-the-digital-era

https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A52021PC0202

Outlook

When exactly in 2023 the proposed EU Machinery Regulation will come into force is not yet known. However, our engineers are already in the starting blocks. Please feel free to ask us.

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