Machinery Directive

The regulations for health and safety requirements in the European Union are to be standardised. As engineering is one of the most important technical subsectors and one of the industrial mainstays of the Union’s economy, regulatory frameworks have been established for the free trade of machinery. These apply to manufacturers and operators as well as those who place machinery on the market within the European Economic Area (EEA).

The most important regulatory framework is the Machinery Directive (MD). Its official title is: Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast).

The Machinery Directive has been applicable since 29 December 2009. The Machinery Directive had to be converted into domestic law in each EU member state. As a regulatory framework, the Machinery Directive also applies outside of the EU, in Switzerland, Turkey and Norway for example, but also in Brazil and Argentina.
The Machinery Regulation 2023/1230 will replace the Machinery Directive on 20 January 2027. This is a key date regulation: from this date, application of the Machinery Regulation is mandatory.

• The machine must be designed to be mechanically and electrically safe. This includes the avoidance of hazards such as moving parts, electrical risks and other potential hazard sources.
• Functional safety must be implemented. For example, this includes the implementation of safety functions, in order to prevent accidents.
• The machine must already be safe at the time it is placed on the market. That means that it must meet all the relevant safety requirements.
• Safe operation of the machine must be guaranteed. This includes aspects such as clear instructions for the operator, easily understandable control elements and ergonomic design.
• Machine safety devices and safeguards must not be easy to defeat, the keyword being manipulation of safety devices. They are the key factor for the protection of operators and other persons.
• Conformity assessment procedures with risk assessment are carried out. This helps to guarantee that the machine meets all the relevant safety requirements.
• Once the assessment is completed successfully, the declaration of conformity is made and the CE mark is applied.
• It is important to produce technical documentation and operating instructions. These should clearly draw the attention of the machine user and operator to any existing residual risks.

Generally speaking, standards are not legally binding in nature, unless they have been published in the Official Journal of the EU or have been transposed into national laws and regulations. Publication of these harmonised standards triggers "presumption of conformity".

• Machinery Regulation
• Machinery Directive
• Functional safety