The Seven Steps to a CE Mark: 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
• 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 to a CE Mark: Step 4, Performing the Risk Assessment

The manufacturer is obliged to carry out a risk analysis to determine all the hazards associated with his machine. The result of this analysis must then be considered in the design and construction of that machine. The contents and scope of a hazard analysis are not specified in any directive, but EN ISO 12100 describes the general procedure.

All relevant hazards must be identified, based on the intended use – taking into consideration all the lifecycles once the machine is first made available on the market. All the various groups who come into contact with the machine, such as operating, cleaning or maintenance staff for example, are also considered.

The risk is assessed and evaluated for each hazard. Risk-reducing measures are established in accordance with the state of the art and in compliance with the standards. The residual risk is assessed at the same time: If it is too high, additional measures are required. This iterative process is continued until the necessary safety is achieved.

Seven Steps to a CE Mark: Step Three, 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.

Seven Steps to a CE Mark: Step Two, Check the Appplication of Additional Directives

Where machinery is also subject to other EU directives, which cover different aspects but also provide for the affixing of the CE mark, the provisions of these directives must be met before the CE mark is applied. If the machine contains electrical equipment, for example, it will often be subject to the Low Voltage Directive and, possibly, the EMC Directive too.

Seven Steps to a CE Mark: Step 1, Categorize the Product

Step 1: Categorize the product
The CE marking process starts by categorizing the product.

The following questions need to be answered:
• Is the product subject to the Machinery Directive?

Here it’s important to note that with the new Machinery Directive coming into force, some new products have been introduced (e.g. pressure vessels, steam boilers and funicular railways), while others have been omitted (e.g. electrical household and office equipment).

• Is the product listed in Annex IV of the Machinery Directive?

Annex IV of the Machinery Directive lists machinery that is  considered “particularly hazardous”, such as presses,  woodworking machinery, service lifts, etc. In this case, CE marking and the declaration of conformity must meet special requirements.

• Is the machine a subsystem or partly completed machinery?

Manufacturers issue an EC declaration of conformity for functional machines that meet the full scope of Annex I of the Machinery Directive. For subsystems, e.g. robots, which cannot yet meet the full scope of
Annex I, the manufacturer issues a manufacturer’s declaration in accordance with Annex II B.

The new Machinery Directive refers to subsystems as “partly completed machinery”. From the moment the new Machinery Directive becomes valid, all partly completed machinery must be accompanied by a declaration of incorporation in accordance with Annex II. At the same time, the manufacturer must perform a risk assessment and provide assembly instructions in accordance with Annex VI. Effectively the  manufacturer’s declaration or declaration of incorporation bans the subsystem from being put into service, as the machine is incomplete and as such may not be used on its own.

• Is it a safety component?

Under the old Machinery Directive, safety components are treated separately and are not awarded a CE mark, although it is necessary to produce a declaration of conformity. Under the new Directive they will be treated as machinery and will therefore be given a CE mark.

Potential assessment procedures in accordance with the new Machinery Directive.

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 Plant and Machinery

According to the Machinery Directive, a machine manufacturer is anyone who assembles machines or  machine parts of various origins and places them on the market.

A manufacturer may be the actual machine builder or – where a machine is modified – the operator. In the case of assembled machinery, it may be the manufacturer, an assembler, the project manager, an engineering company or the operator himself, who assembles a new installation from various machines, so that the different machine parts constitute a new machine.

However, according to the Machinery Directive, only one manufacturer is responsible for the design and manufacture of the machine. This manufacturer or his authorized representative takes responsibility for implementing the administrative procedures for the entire plant. The manufacturer may appoint an authorized representative, who must be established in the EU, to assume responsibility for the necessary procedures for placing the product on the market:

• Compiling the plant’s technical documentation
• Complying with the technical annex
• Providing operating instructions for the plant
• Affixing the CE mark in a suitable position on the plant and drawing up a declaration of conformity for the  entire plant

It’s important that the manufacturer considers the safety aspect early, as the contracts are being formulated or in the components’ requirement manual. The documentation shall not be compiled solely from the point of view of machine performance. The manufacturer is responsible for the whole of the technical documentation and must determine the part that each of his suppliers is to undertake in this process.

Use of machinery in the European Economic Area
Irrespective of the place and date of manufacture, all machinery used in the European Economic Area for the fi rst time from 01.01.1995 is subject to the EU Machinery Directive and as such must be CE certified.

Assembled machinery
On large production lines a machine may often consist of several individual machines assembled together. Even if each of these bears its own CE mark, the overall plant must still undergo a CE certification process.