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Machinery Directive (2006/42/EC) - Certification Guide

23/4/2023 Ferry Vermeulen Law & Legislation

1. What is the Machinery Directive 2006/42/EC?

The Machinery Directive 2006/42/EU is a European Directive and falls within the scope of CE marking. It sets requirements for machines, safety components, lifting accessories (such as chains and ropes) and other related products.

Machinery is any assembly of components, of which at least one moves, joined together to perform a specific function. Such an assembly does not require human or animal effort, but is instead powered by energy.

The machinery directive applies not only to machinery but also to safety components and lifting accessories such as chains and ropes.

The purpose of the machinery directive is:

  • To encourage free movement of machinery within EU member states
  • To promote a high level of safety for workers as well as citizens

2. Directive Name

Machinery Directive.

3. Directive Number & Download Link to Legal Directive

Directive 2006/42/EC can be downloaded from the following link:

Machinery Directive 2006/42/EC

4. Notified Body (aka, Independent Assessment) Required?

Before a manufacturer can begin the required procedure to assess their product for conformity, it is important that they determine whether said product allows self-assessment or if a Notified Body needs to be involved.

A notified body is an organisation which is responsible for carrying out required conformity tests to assess products before they are released to the EU market. These bodies are designated by individual European Union member states.

Most of the equipment which fall under this directive can be self-assessed by manufacturers. So long as the equipment complies with the directive, manufacturers need not approach a notified body 

There are  23 exceptions in the category of machinery, listed under Annex IV of the directive, which are subject to special assessment procedures. The equipment mentioned in Annex IV of the machinery directive must either be manufactured in staunch accordance with the standards provided or be subjected to assessment by notified bodies.

5. Products Covered

The machinery directive applies to any assembly of components, at least one of which moves, joined together to carry out a specific operation. Also, all the lifting equipment, including chains, ropes and slings as well as safety components are covered by the machinery directive. According to this definition, the scope of this directive is large and consists of a huge number of machines.

6. Examples of Products Covered

The types of products covered by the Machinery Directive include the following:

  • Commercial dishwashing machines
  • Commercial washing machines
  • Commercial whirlpool baths and spas
  • Milking equipment
  • Commercial floor cleaning and treatment machines
  • Commercial microwave ovens with moving parts

7. Examples of Products NOT Covered

Some types of equipment which are not covered by this directive are:

  • Safety components which are used as spare parts and are provided by manufacturers to replace original identical components
  • Equipment to be used in fairgrounds and amusement parks
  • Weapons
  • Machinery designed for nuclear purposes
  • Means of transport covered by other directives
  • Seagoing vessels and mobile offshore units, including equipment on board such vessels and units
  • Machinery designed for police or military
  • Machinery designed for research in temporary laboratories
  • Mine winding gear
  • Machinery designed to move artists during their performances
  • Low voltage equipment which are covered by Low Voltage Directive
  • High voltage equipment such as transformers, switch gears and control gears

8. Enforcement & Penalties

Each EU member state is required to lay down rules on penalties for not complying with the Machinery Directive. Below you can find the penalties for member states Germany and the UK as an example. For penalties relevant to other specific EU member states, please consult that state's local legislation on product safety.

  • Germany - violation of the "Produktsicherheitsgesetz" (product safety legislation) can result in fines of €3,000 - €30,000 (§ 19) and imprisonment of up to 1 year (§ 20).
  • In the UK, directive violations are are covered under Section 33 HSWA offenses and can result in an unlimited fine and up to two years imprisonment.

9. How to Comply: Requirements & Process

Check Conformity

Most of the equipment under this directive can be assessed by manufacturers for conformity.

Only certain equipment under Annex IV of the directive requires notified bodies to be involved for conformity assessment procedures.

Declaration of Conformity (contents)

The basic layout and content of a declaration of conformity are common for all directives, but may differ slightly for each directive 

The following are required by most directives:

  • Manufacturer’s name and address
  • The equipment’s description and/or serial number
  • Reference to relevant harmonized standards
  • Reference to the specifications, where necessary, by which conformity is declared
  • Details of the signatory
  • The two ending digits of the year of CE mark affixation

Technical Documentation

Directive 2006/42/EC requires technical documentation to be established by the manufacturer. The technical document is instrumental in the assessment of the conformity of said appliance with the Directive’s requirements.

The technical document must contain the following elements:

  • Description of the equipment
  • Abstract design, manufacturing drawings, diagrams of components, sub-assemblies, circuits, etc.,
  • Descriptions and any explanations which are necessary to understand the drawings and diagrams, as well as the operation of the equipment
  • List of the harmonised standards
  • Results of design calculations and examinations
  • Test reports
  • Instruction manual (template for user manual)

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Affix CE Mark

When all the necessary steps have been taken, it is time to get the product affixed with the CE mark. The mark should be placed either on the equipment, the packaging or the instructions. The letters must be vertically equal in dimensions and must not be smaller 5 millimeters. If there are other Directives which cover the product as well, the CE marking must be affixed only when all the Directives have been met.

10. Template Download

For a free Declaration of Conformity template for the Machinery directive, please refer to the downloads section of the page below:

Declaration of Conformity Templates.

We also offer (paid) templates for creating compliant user manuals for machinery.

11. Related Directives

The directives that fall under the Mechanical Engineering sector, other than the Machinery Directive, include:

12. Useful Links (testing Labs, further information)

Links you might find useful in gaining more information regarding the Pressure Equipment Directive.

   

Ferry Vermeulen is a technical communication and compliance expert. He also is a parttime trainer at the Dutch standardisation institute (NEN). Listen to the INSTRKTIV podcast on Spotify or read one of his latest blog articles. 

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