EFS Consulting

New EU draft Machinery Regulation

The European Commission published a new draft of the Machinery Regulation which would replace the existing Machinery Directive

A proposal of the Machinery Regulation is a part of the EU initiative to make Europe fit for the Digital Age and is accompanied by a Regulation laying down harmonized rules on artificial intelligence (Artificial Intelligence Act).  The new Machinery Regulation will ensure the safe integration of the AI system into the overall machinery. Businesses will need to perform only one single conformity assessment.

The new Machinery Regulation is also supposed to solve the following problems linked with the existing legislation:

  • the Machinery Directive does not sufficiently cover risks originating from emerging technologies
  • legal uncertainty due to a lack of clarity on the scope and definitions
  • insufficient provisions for high-risk machines
  • monetary and environmental costs due to extensive paper-based documentation
  • inconsistencies with other pieces of EU product safety legislation
  • divergencies in interpretation due to transposition

It is noteworthy that the new piece of legislation will be a regulation instead of a directive which means that it will apply directly in member states and a transposition will not be necessary.  As a result, the Machinery Regulation will be the first such product-related piece of legislation (others, such as Radio Equipment Directive or Low Voltage Directive are directives).

The draft stipulates that the new regulation will be applicable 30 months after its official publication. (The date refers to the actual adoption of the final version, not to the draft, which may still change in many places).

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Compliance and Legal


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