Machinery for own use

CE certification for individual machines and the overall plant.

The Machinery Directive also obliges users who manufacture machinery for their own use to comply with the Directive. Although there are no problems in terms of free trade - after all, the machine is not to be traded - the Machinery Directive is applied to guarantee that the safety level of the new machine matches that of other machines available on the market.

Importing a machine from a country outside the EU

When a machine is imported from a third country for use within the EU, that machine must comply with the Machinery Directive when it is made available on the EU market.Anyone who places a machine on the market for the first time within the European Economic Area must have the necessary documentation to establish conformity, or have access to such documentation. This applies whether you are dealing with an  “old machine” or new machinery.

CE Marking of Machinery: What is a machine?

For the purposes of the Directive, one definition of a machine is:

An assembly of linked parts or components, at least one of which moves, and which are joined together for a specific application. (see Article 2 of the Machinery Directive)

Example of a machine for the purposes of the Directive.

 

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

• An assembly of machines or complex plants (complex plants include production lines and special purpose machinery made up of several machines)
• Safety components (The issue of which components to classify as safety components is very controversial. As yet there is no discernible, uniform trend.)
• Interchangeable equipment that can modify the basic functions of a machine.

There is also a list of exceptions where machinery falls under the scope of the Directive by definition, but for which other statutory provisions generally apply.

Legal Principles of the CE Mark and the Machinery Directive

The obligation to affix CE marking extends to all products which fall under the scope of directives providing for such marking and which are destined for the single market. CE marking should therefore be affixed to the following products that fall under the scope of a directive:

• All new products, irrespective of whether they were manufactured in member states or third-party  countries
• Used products imported from third-party countries and second hand products
• Products that have been substantially modified and fall under the scope of the directives as new products.

The directives may exclude certain products from CE marking.

The manufacturer uses the declaration of conformity to confirm that his product meets the requirements of the relevant directive(s).

The information that follows is intended to explain CE marking in terms of the Machinery Directive.

The Basis of Machine Safety: Machinery Directive and CE mark

When the Machinery Directive (MD) was ratified in 1993, the aim was to remove trade barriers and enable a free internal market within Europe. After a two-year transition period, the Machinery Directive has been binding in Europe since 01.01.1995. It describes standardized health and safety requirements for interaction between man and machine and replaces the host of individual state regulations that existed on machinery safety. The new Machinery Directive 2006/42/EC has applied since 29.12.2009.

The CE mark stands for “Communauté Européenne”. A manufacturer uses this mark to document the fact that he has considered all the European internal market directives that are relevant to his product and applied all the appropriate conformity assessment procedures. Products that carry the CE mark may be imported and sold without considering national regulations. That’s why the CE mark is also referred to as the “Passport to Europe”.

Generally speaking, all directives in accordance with the new concept (“new approach”) provide for CE marking. Where a product falls under the scope of several directives which provide for CE marking, the marking indicates that the product is assumed to conform with the provisions of all these directives.

Pilz Helps Exporters in Wind Industry Get CE Mark

Wind turbine companies wishing to export to the European Union need to get their products CE marked or they will not be compliant with European law.  A declaration of conformity for wind turbines is necessary because by definition, a wind turbine is a functional machine, and as such it falls within the scope of the Machinery Directive 2006/42/EC.

For this reason wind turbines need to be issued with a declaration of conformity in accordance with Annex IIA of the Machinery Directive and will also be subject to the CE marking process.  The CE marks confirms that a machine conforms to the European directives.

Pilz Automation Safety can guide companies through all the phases en route to CE certification for wind turbines. 

Pilz offers risk analysis as the basis for the declaration of conformity.  This procedure is based on a thorough, competently executed and systematic risk analysis that detects and evaluates potential hazards and then employs appropriate safeguards to reduce these hazards. The result of the risk analysis is then incorporated into the development of an appropriate safety concept.

Pilz offers wind turbine manufacturers comprehensive support in performing the risk analysis.  The risk analysis includes identification of applicable standards, and regulations and best industry practices.  The analysis also includes determination of the limits of the wind turbine, examination of all the hazards throughout the entire lifecycle and all operational phases.  The analysis also contains the recommended approach for reducing risk, based on the current standards.

Also, Pilz engineers have developed a methodology for testing safety-critical elements on wind turbines, based on decades of experience in machine validation. It examines whether the implemented safety measures meet all the requirements. The test applied during validation covers:

• Assessment of the selected components
• Assessment of the implemented designs in comparison with the safety requirements
• Implementation of a function test and fault simulation
• Test of the safety-related software and hardware functions
• Test of the sensor/actuator technology and its wiring
• Production of a test report with detailed information about the results

Not sure of the official directive title? The abbreviation? Directive number?

Of the almost 30 active directives now available, only a small selection is relevant to the typical machine builder. In addition to the directive number (e.g. 2006/42/EC), some directives may have a very long or bureaucratic title. As a result it is generally very difficult to name the directive. These long titles are often abbreviated separately, even though this can also lead to misunderstandings. Here is a list of some of the key directives with both their official title and their usual, though unofficial, abbreviated title:

The goal of the directives is to guarantee freedom of movement within the EU. The full texts of the directives are available from the EU at http://eur-lex.europa.eu/de/legis/index.htm.

The Seven Steps of CE Marking Explained: Step 6- Issue the Declaration of Conformity

Step 6: Issue the declaration of conformity

By issuing the EC declaration of conformity the manufacturer declares that they have considered all the directives that apply to the product. The person signing an EC declaration of conformity must be authorized to represent their company. This means that the signatory is legally entitled to execute a legal transaction, such as signing the EC declaration of conformity, on account of their job function.

When an authorized employee of the company adds their valid signature to an EC declaration of conformity, they trigger the liability of the natural responsible person and, if applicable, the company as a legal entity.

The declaration may also be signed by an authorized representative, who is established in the EU.

The new Machinery Directive requires the declaration to name the person authorised to compile the technical documentation. This person must be established in the EU.

The Seven Steps of CE Marking Explained: Step 5- Compile The Technical Documentation

Step 5: Compile the technical documentation

In accordance with the Machinery Directive, technical documentation specifically comprises:

• An overall drawing of the machinery and drawings of the control circuits
• Full, detailed drawings (accompanied by any calculation notes, test results, etc.) required to check the conformity of the machinery with the essential health and safety requirements 
• A list of the essential requirements of this directive, standards and other technical specifications used in the design of the machinery, a description of the protective measures implemented to eliminate hazards presented by the machinery (generally covered by the risk analysis)
• Technical reports or certificates; reports or test results showing conformity
• The machine's operating instructions

Under the new Machinery Directive, the following are also required:

• A general machine description
• Declaration of conformity or declaration of incorporation plus the assembly instructions
• Declarations of conformity for the machines or devices incorporated into the machinery

This documentation does not have to be permanently available in material form. However, it must be possible to assemble it and make it available within a period of time commensurate with its importance. It must be retained for at least ten years following the date of manufacture and be available to present to the relevant national authorities. In the case of series manufacture, that period shall start on the date that the last machine is produced.

The Seven Steps of CE Marking Explained: Step 3- Ensure that Safety Regulations are Met

Step 3: Ensure that safety regulations are met

It is the responsibility of the machine manufacturer to comply with the essential health and safety requirements in accordance with Annex I of the Machinery Directive. The formulation of these requirements is relatively abstract, but specifics are provided through the EU standards.
The EU publishes lists of directives and the related harmonized standards. Application of these standards is voluntary, but compliance does provide presumption of conformity with the regulations. This can substantially reduce the amount of evidence required, and a lot less work is needed to incorporate the risk assessment.