Machinery Directive (MD)

Symbol for the interaction of standards

Official title of the Machinery Directive: 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). It has applied since 29.12.2009. Irrespective of the place and date of manufacture, all machinery used in the European Economic Area for the first time from 01.01.1995 is subject to the EU Machinery Directive and as such must be CE certified.

 

The Machinery Directive is one of the most important pieces of legislation for harmonising the essential safety requirements for machinery within the European Union. It describes standardised health and safety requirements for interaction between human and machine. The Directive promotes the free movement of machinery within the single market and guarantees a high level of protection for EU workers and citizens.

News relating to the Machinery Directive

The EU Commission has further developed the Machinery Directive to become the Machinery Regulation (MR), in order to improve safety levels further, take account of security aspects and stay abreast of new technological developments.

The EU Machinery Regulation was published in the Official Journal of the European Union in 2023. However, its application does not become mandatory until 20 January 2027.

Conformity assessment procedure in accordance with the Machinery Directive

Two men and a woman wearing hard hats are standing on a shop floor looking at a tablet

Plant or machinery that is placed on the market must be provided with a Declaration of Conformity and must carry a CE mark. With this the manufacturer assures that the product meets the essential health and safety requirements of all relevant directives and regulations. With partly completed machinery, the Declaration of Conformity and CE marking is replaced by a Declaration of Incorporation plus assembly instructions.  The Directive states that the conformity assessment procedure must be completed in full by the time the machine is first placed on the market. The application of harmonised standards is voluntary, but it can simplify the conformity assessment.

For most machines, a manufacturer can take responsibility for declaring compliance with the Directive by issuing an EC Declaration of Conformity and attaching a CE mark. However, for some machines and safety components with high risk potential, which fall within the scope of Annex IV of the Directive, a notified body (e.g. a test and certification body) must be involved in the conformity assessment by carrying out a type examination or monitoring a full quality assurance procedure.

The Machinery Directive 2006/42/EC requires manufacturers of plant and machinery as well as partly completed machinery to carry out and document a risk assessment. Annex I, General Principles No. 1 of the MD states the following: “The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment”.

What is a machine in accordance with the Directive?

For the purposes of the Directive, machinery means an assembly consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application.

The following are also considered as machinery for the purposes of the Machinery Directive:

  • Assembly of machines or complex plants. Complex plants include production lines, special purpose machinery made up of several machines, interlinked machinery
  • Safety components: The issue of which components are classified as safety components is very controversial. As yet there is no discernible, consistent trend
  • Interchangeable equipment that can modify the basic functions of a machine
  • Partly completed machinery: can "still" not fulfil any functions, because they must be incorporated into another machine or combined with other machine parts to form a plant, for example.

In addition to the machinery listed above there is also a list of exceptions for machinery, which would fall under the scope of the Directive by definition, but for which other statutory provisions generally apply.

Pilz emergency stop switch on a safety gate

What do we mean by an assembly of machines?

Under the terms of the Machinery Directive 2006/42/EC, we refer to an assembly of machines when individual machines interact or are arranged in such a way that they are considered to be a self-contained unit.

This means that plant components

  • are arranged in such a way that they are considered to be one unit (particularly spatially connected)
  • interact as an assembly, i.e. interaction is aimed at a common goal (e.g. producing a paper web)
  • are operated as an assembly (joint or linked control)
  • function as an assembly and form one unit in terms of safety.

What does not represent an assembly of machines?

There can be no assembly of machines under the terms of the Machinery Directive when an overall complex has individual standalone machines or subsystems that are connected in terms of function and control, but do not form a unit in terms of safety, for example. This is the case, for example, when only minor safety hazards, if any, occur at the interfaces on account of the link.

It can be summarised as follows: If there is a production-related and safety-related connection between the machines, then that constitutes an assembly of machines under the terms of the Machinery Directive. As a result, an EU Declaration of Conformity and CE marking must be prepared for the assembly of machines.

If there is no production-related or safety-related connection, then an EU Declaration of Conformity and CE marking for the individual machines is “enough”.

Guide to the application of the Machinery Directive

Guide to the application of the Machinery Directive 2006/42/EC

The practical "Guide to application of the Machinery Directive 2006/42/EC" is used to interpret the text of the Directive. Version 2.2 has been published and can be downloaded from the European Commission's website. The main differences between the current version and the previous Version 2.1 are the additions and clarifications, particularly with regard to the terms “safety components” and “partly completed machinery”, plus some edits to guarantee coherence with the guidelines for the Low Voltage Directive.

A short section about the safety-related requirements has been added in the section entitled “Mode selection” (§204). Two new paragraphs have also been added regarding machinery control units (§417) and safety components which are considered to be logic units (§418).

Presentation: What does the future hold for machinery safety?

Pilz Automation Days presentation: What does the future hold for machinery safety?

Machinery safety is the basis for effective, accident-free cooperation between human and machine. New approaches and issues, such as digitisation for example, require ongoing development of the directives and standards applicable today. In his keynote speech, Klaus Stark explains where that journey might lead.

Harmonised standards in accordance with the Machinery Directive at a glance

Poster on safeguards for plant and machinery

Navigating the jungle of standards! The poster on “Safeguards for plant and machinery – Important harmonised standards according to the Machinery Directive” clearly presents the A/B and C standards. At the same time you get a condensed overview of our safety-related products.

Download the poster now!

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