Machinery Directive becomes Machinery Regulation

The Machinery Directive 2006/42/EC has for many years been the central regulatory framework for the European internal market. It defines the essential health and safety requirements for placing machinery on the market. Manufacturers must demonstrate that their machines comply with these requirements before they may be affixed with the CE marking and placed on the market.

The Machinery Directive 2006/42/EC remains valid until 19 January 2027 and will then be replaced by the Machinery Regulation (EU) 2023/1230. Unlike a directive, which must first be transposed into national law by the EU Member States, a regulation has direct and uniform legal effect in all Member States. From 20 January 2027 onwards, machinery may only be placed on the market in accordance with the provisions of the new regulation.

Key differences compared with the previous Directive:

• Direct applicability: No transposition into national law is required.
• New technologies: Topics such as artificial intelligence and cybersecurity have been included.
• Digital instructions for use: Permitted for the first time, although subject to certain restrictions.
• Substantial modification: The term is now regulated in a legally binding manner; anyone who fundamentally modifies a machine may legally become the manufacturer.
• Third-party involvement: For certain categories of machinery, stricter conformity assessment requirements apply, involving external bodies even where harmonised standards are complied with.