The new machinery regulation has been finally adopted

Deadlines and updates

The vote in the European Parliament (EP) on the proposal for a regulation on machinery products produced a clear result on April 18, 2023: with 595 votes out of 632, the new Machinery Regulation was clearly approved at first reading. 

On May 22, 2023, the European Council has now finally adopted the new Machinery Regulation. It replaces the Machinery Directive 2006/42/EC. After signature by the President of the European Parliament and the President of the Council, the Regulation will be published in the Official Journal of the European Union and will enter into force on the twentieth day following its publication. Member States and economic operators will have 42 months to apply the rules of the new regulation.

However, the following articles shall apply from the following dates: 

  • (a) Articles 26 to 42 from ... [six months after the date of entry into force of this Regulation]; 
  • (b) Article 50(1) from ... [39 months after the date of entry into force of this Regulation]; 
  • (c) Article 6(7), Article 48 and Article 52 from ... [the date of entry into force of this Regulation]; 
  • (d) Article 6(2) to (6) and (11), Article 47 and Article 53(3) from ... [twelve months after the date of entry into force of this Regulation]. 

This Regulation is binding in its entirety and directly applicable in all Member States, and therefore obviously not in the United Kingdom.

The new Machinery Regulation has the necessary flexibility to accommodate emerging technologies, including the future use of artificial intelligence in the machinery sector. But there will also be new requirements, such as cybersecurity, for the industry. And the problem child of "harmonized standards" will also leave its mark on the new Machinery Regulation (see Article 20 (3) of the new MVO). 


There are also the following innovations, among others, for the EU declaration of conformity to be issued as well as the EU declaration of incorporation (Annex V): 

  • For lifting machines that are to be permanently installed in a building or a structure and that cannot be assembled on the manufacturer's premises but only at the place of use, the address of this place must be indicated in the EU declaration of conformity. 
  • In the case of partially applied harmonized standards or common specifications, the parts that have been applied shall be indicated in the EU declaration of conformity or the EU declaration of incorporation. 


Structurally, the changes in the new Machinery Regulation are most evident, but new legal terms have also been added (not a complete listing of all changes): 

  • The Machinery Regulation corresponds to the model provisions of Decision 768/2008/EC and is thus the last provision to have been adapted to the "New Legislative Framework". 
  • Chapter II lists the individual legal obligations for manufacturers, authorized representatives, importers (new) and distributors (new). 
  • The original Annex I of the old Machinery Directive is now Annex III and describes the essential health and safety requirements for the design and construction of machinery or associated products. 
  • The term "substantial change" has been added. 
     

We will highlight the new Machinery Regulation in a tutorial during our 11th GLOBALNORM Product Compliance Conference on November 29 and 30, 2023 (in german), as well as address individual aspects of the new regulation in other planned events. Please feel free to inform yourself via our website.

If you need discussion or clarification, feel free to contact our team of experts!

Published on 19.04.2023
Category: Haftungsverantwortung und Pflichten, Fokus Industry, Compliance

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