Machinery Directive 2006/42/EC: what it really provides and why it is still central to business

Scope: what really comes under the Directive

The Directive covers not only machines in the strict sense, but also interchangeable equipment, safety components, lifting accessories, mechanical transmission devices and quasi-machines.
The concept of “machine” is broader than is often imagined. It is defined as a set of interconnected parts or components, at least one of which is movable, intended for a specific function. This definition also includes sets of machines, such as production lines or complex plants, when they function as a coordinated unit both from a production point of view and from a safety perspective.
However, not all equipment falls within the scope of application. The Directive excludes, for example, certain particular categories such as machines for military use or used in specific sectors governed by different regulations
Understanding the application perimeter correctly is essential to avoid interpretative errors, especially in borderline cases

The responsibility of the manufacturer: the heart of the Directive

The centre of the Directive is not CE marking, but risk assessment.
The manufacturer is required to carry out a risk analysis to identify which essential safety and health protection requirements apply to the machinery. The design and construction shall be consistent with the results of that assessment.
This is not a formal fulfillment: it is a process that influences the entire design phase. The manufacturer must identify limits of use, identify potential risks and take appropriate measures to reduce them. Only at the conclusion of this route can it declare conformity and affix the CE marking. 
There is a clear rationale behind this: security must be built into the design, not added later.

CE Marking: What It Really Certifies

The CE marking is often perceived as a simple graphic symbol, but represents the manufacturer's assumption of responsibility. It must be affixed in a visible, legible and indelible manner and may not be accompanied by signs altering its meaning.
With the CE marking the manufacturer declares that the machinery complies with all the applicable essential requirements and that the conformity assessment procedure has been correctly completed. For quasi-machines, on the other hand, the CE marking does not apply but a declaration of incorporation is issued, accompanied by instructions for assembly.
Behind the CE mark there is therefore a technical file, structured documentation and precise legal responsibility.

Harmonized standards and presumption of conformity

One of the most sensitive aspects concerns the relationship between essential requirements and harmonized standards.

Health and safety requirements are mandatory. Harmonized standards, on the other hand, are voluntary, but compliance with them allows them to benefit from the so-called “presumption of conformity”. In other words, if the manufacturer applies a harmonised standard published in the Official Journal of the European Union, the machinery is presumed to meet the corresponding essential requirements.

It is an important distinction: the Directive lays down what is to be guaranteed; technical standards provide one of the possible ways of proving this.

Recent changes and emergency procedures

Over the years, the Directive has been updated to adapt to technological developments and market needs. Among the most recent amendments are provisions allowing, in emergency situations in the internal market, accelerated procedures for placing on the market goods relevant to the crisis.

In such cases, conformity assessment bodies must give priority to strategic products and, in exceptional circumstances, extraordinary arrangements may be made to avoid critical disruptions in the supply chain.

This is a mechanism designed to ensure resilience without lowering the level of protection.

The transition to the Machinery Regulation 2023/1230

Directive 2006/42/EC has been repealed and replaced by Regulation (EU) 2023/1230, which will become fully applicable from 20 January 2027.

The change from Directive to Regulation is not only formal. The Regulation will apply uniformly in all Member States, increasing legal certainty. Furthermore, it integrates aspects that are central to the industrial context today: software with security functions, artificial intelligence, cybersecurity and the digitization of documentation.

The basic structure remains that of essential requirements and risk assessment, but the framework is updated to the state of the art of technology.

Why talk about it today

To talk today about the Machinery Directive is to understand the foundations on which the new European regulatory system will be built.

Machine safety is no longer just a mechanical issue. It is a theme that involves design, human-machine interaction, software integration, control system protection, and accountability throughout the supply chain.
For companies that design, integrate, or modify machines, a thorough understanding of the current Directive is the first step in consciously addressing the regulatory evolution that will finally come into force in 2027.

To receive more information about the world of viteria, subscribe to our newsletter. 
Contact us at commerciale@univiti.it to receive a free quote.