tekom - Europe
05/07/23

New Machinery Regulation published

Magali Baumgartner, Gabriela Fleischer


On June 29, 2023, REGULATION (EU) 2023/1230 on machinery was published in the Official Journal of the European Union. 
Here are the key points with regard to technical communication.

The scope of the Machinery Regulation remains almost the same compared to the Machinery Directive 2006/42/EC, except for changes in two definitions:
→ "safety components"
→ "partly completed machinery"

Paper version on request
In the Machinery Regulation, Article 10 is significant for the instructions for use in digital format. Newly included in Article 10 (7) is the possibility of supplying the instructions for use in digital format. How to access the digital instructions shall be indicated on the "machinery" or on the "related product". The manufacturer shall provide a free paper version, at request of the user at the time of the purchase within one month.
In the case of machinery or a related product are business-to-consumer(B2C) products and are intended for "non-professional users" or can under foreseeable conditions be used by them, the manufacturer shall provide the essential safety information for putting the machinery or related product into service and use them safely in paper format. The consideration about the essential safety information must be done within the risk assessment.

Digital assembly instructions possible
Manufacturers of partly completed machinery can also provide assembly instructions in digital format according to Article 11 (7). They shall present the digital assembly instructions in a format that makes it possible for the person who incorporates the partly completed machinery to print the instructions or download them – the instructions must be accessible for the person at all times. However upon request of the person who incorporates the machinery at the time of the purchase the manufacturer shall provide a free paper version within one month.
EU declarations of conformity or declarations of incorporation can also be provided digitally.
It is possible that the new requirements of the Machinery Regulation in Annex III in relation to cybersecurity and artificial Intelligence may result in additions for the instruction handbook.


Change of structure and entry into force


The Machinery Regulation has a different structure:
→ Annex I of the Machinery Directive 2006/42/EC is Annex III of the Machinery Regulation.
→ Annex IV of the Machinery Directive 2006/42/EC is Annex I of the Machinery Regulation.

The Machinery Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the EU. It shall apply from 20 January 2027. However, for some designated articles, there are other dates of entry into force.