CE Marking of Machinery

How can ARC Management Systems help with CE Marking Machinery?

The CE Marking consultancy service we provide includes:

  • Identify and applying all the appropriate directive(s).
  • Identifying necessary standards to meet requirements.
  • Conducting full Risk Assessments.
  • Testing of product or characteristics.
  • Produce the Technical File.
  • Produce User & Service Manual specifically the product.
  • Produce Declaration of Conformity.

We will handle all aspects of the CE process and guide and advise on any changes which may be necessary to ensure your product is in conformance with all CE requirements.

When does a Machine need to be CE Marked?
  • Where the manufacturer of relevant machinery himself puts that machinery into service or places it for sale within the EU.
  • Where having imported machinery from a country or territory outside the EU, puts that machinery into service.
  • If you are creating a complex assembly by interlinking a series of existing machines you are in effect creating something new.
  • If you are altering the function or performance of a machine or complex assembly, you are again creating something new and must ensure that the Directive is complied with.
What does the Manufacture, Importer or Distributor need to do?
  • Produce a complete technical file that meets the requirement of the Machinery Directive.
  • Issue a User & Service Manual than contains the required information as detailed in the Machinery Directive.
  • Issue a Declaration of Conformance

Machinery Directive Process

  1. 1
    Step 1 – Identify the Appropriate Directive or Directives

    The machinery directive applies to the following products:

    • Machinery

    • Interchangeable equipment

    • Safety components

    • Lifting accessories

    • Chains, ropes and webbing

    • Removable mechanical transmission devices

    • Partly completed machinery

    CE Marking Machinery

  2. 2
    Step 2 – Identify the Applicable Requirements of the Machinery Directive
    A risk assessment is carried out on the product based on the Machinery Directives requirements. There is risk assessment carried out on machinery and partly completed machinery.
    Risk Assessment for machinery

    The risk assessment must include the following information:

    • The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery
    • A list of the health and safety requirements which apply to the machinery

    Risk Assessment for partly completed machinery

    The risk assessment should include the following information:

    • A list of the essential health and safety requirements applied and fulfilled,
    • The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,
    • The standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,
    • Any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
    • A copy of the assembly instructions for the partly completed machinery;
  3. 3
    Step 3 – Identify the Appropriate Requirement for Conformity to the Machinery Directive
    There are a number of standards under each directive which the product must comply with:
    The classification of machinery standards

    The Machinery standards are classified into three different types A, B and C:

    A-type standards

    A-type standards specify basic concepts, terminology and design principles applicable to all categories of machinery.

    B-type standards

    B-type standards deal with specific aspects of machinery safety or specific types of safeguard that can be used across a wide range of categories of machinery.

    C-type standards

    C-type standards provide specifications for a given category of machinery such as, for example, mechanical presses, combine harvesters or compressors.

  4. 4
    Step 4 – Conduct the Assessment of the Product
    Machinery Requiring Third Party Assessment

    This section describes categories of machinery that requires assessment of conformity by the manufacturer or by a third party assessment by parties such as the manufacturer’s authorised representative or an EC type examination by a notified body where the notified body makes sure and confirms that the machinery satisfies the provisions of the machinery directive or where the notified body assesses and approves the quality system and monitors its application.

    Circular Saws
    • Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
    Fixed Blade Sawing Machinery
    • sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;
    • sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
    • sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
    Moveable Blade Sawing Machinery
    • sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading
    Planing Machinery
    • Hand-fed surface planing machinery for woodworking
    Thicknessers
    • Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking
    Bandsaws
    • Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
    Fixed Blade Sawing Machinery
    • Sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
    Sawing Machinery
    • Sawing machinery with blade(s) assembled on a carriage with reciprocating motion
    Combined Machinery
    • Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.
    Hand –Fed Tanning Machinery
    • Hand-fed tenoning machinery with several tool holders for woodworking
    Hand-fed Verticle Spindle Moulding Machinery
    • Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics
    Portable Chainsaws
    • Portable chainsaws for woodworking
    Presses
    • Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
    Injection or Compression Plastics-Moulding Machinery
    • Injection or compression plastics-moulding machinery with manual loading or unloading
    Injection or Compression Rubber-Moulding Machinery
    • Injection or compression rubber-moulding machinery with manual loading or unloading
    Underground Machinery

    Machinery for underground working of the following types:

    • Locomotives and brake-vans;
    • Hydraulic-powered roof supports.
    Trucks
    • Manually loaded trucks for the collection of household refuse incorporating a compression mechanism
    Transmission Devices
    • Removable mechanical transmission devices including their guards
    Transmission Devices Guards
    • Guards for removable mechanical transmission devices
    Vehicle Servicing Lifts
    • Vehicle Servicing Lifts
    Lifts
    • Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres
    Impact Machinery
    • Portable cartridge-operated fixing and other impact machinery
    Protective Devices
    • Protective devices designed to detect the presence of persons
    Safeguards
    • Power-operated interlocking movable guards designed to be used as safeguards in presses, injection or compression plastics-moulding machinery and injection or compression rubber-moulding machinery
    Logic Units
    • Logic units to ensure safety functions
    ROPS
    • Roll-over protective structures (ROPS)
    FOPS
    • Falling-object protective structures (FOPS)
  5. 5
    Step 5 – Compile the Technical Documentation
    The Machinery Technical File

    The section describes the process of compiling a technical file. The technical file shows that the machinery complies with the Directives requirements. The design, manufacture and operation of the machinery must be described appropriately for this assessment. The technical file must be created in one or more of the official Community Languages except for the machinery instructions.

    The technical file contains the following information:

    General Description

    A general description of the machinery is required

    Technical Drawings

    The technical drawings should include the following:

    • An overall drawing of the machinery must be included
    • Control Circuit Drawings must be included
    • Machinery description and explanations of the machinery operation must be included
    • It must also include full detailed drawings, accompanied by calculations, test results, certificates, etc., which are required to check the conformity of the machinery with the essential health and safety requirements
    Risk Assessment

    The risk assessment must include the following information:

    • A list of the health and safety requirements which apply to the machinery
    • The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery
    Technical Specifications

    The standards and other technical specifications used which indicate the health and safety requirements covered by these standards

    Test Results

    Technical reports which give the results of the manufacturer’s tests or the results of the tests carried out by a body selected by the manufacturer or his authorised representative must be included

    User Service Manual

    A copy of the instructions for the machinery must be included

    This is a list of the information that is required in a machines user service manual in one or more official community languages in order for the user to be able to operate the machine, maintain the machine and to deal with health and safety issues:

    • Declaration of Conformity
    • Manufacturer’s Name and Address
    • General Description
    • Operation of Machinery
    • Accident and Breakdown Operation of Machinery
    • Maintenance
    • Transport, Handling and storage operations
    • Noise Emissions
    • Technical Drawings
    • Control Circuit Drawings
    • Health and Safety Warnings
    • Instructions for different categories of machinery

    All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

    The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.

    By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.

    Foodstuffs machinery and machinery for cosmetics or pharmaceutical products:

    The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

    Portable hand-held and/or hand guided machinery:

    The instructions must give the following information concerning vibrations transmitted by portable handheld and hand-guided machinery: − the vibration total value to which the hand-arm system is subjected, if it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, this must be mentioned, − the uncertainty of measurement.

    These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

    If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.

    The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied, must be specified.

    Portable Fixing and Other Impact Machinery

    The instructions must give the necessary information regarding:

    • the accessories and interchangeable equipment that can be used with the machinery,
    • the suitable fixing or other impacted elements to be used with the machinery,
    • where appropriate, the suitable cartridges to be used
    Declaration of Incorporation

    The declaration of incorporation for included partly completed machinery and the assembly instructions for such machinery when appropriate

    Declaration of Conformity

    Copies of the EC declaration of conformity of machinery or other products incorporated into the machinery must be included where appropriate

    Maintaining Conformity

    For series manufacture, the internal measures which will be implemented so that the machinery stays in conformity with the Directives provisions

    Component Testing

    The manufacturer must carry out research and testing on components, fittings or on the completed machinery in order to determine whether by its design or construction it is possible to assemble and put into service safely. The relevant reports and results must be included in the technical file.

    Technical File Availability

    The technical file must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.

    Technical File Location

    The technical file does not have to be located within the Community, nor does it have to be permanently available in material form. However, it must be possible to assemble and be made available within a period of time in proportion to its complexity by the person designated in the EC declaration of conformity.

    Subassemblies

    Detailed plans or other specific information does not have to be included in the technical file regarding the subassemblies used for the manufacture of the machinery unless knowledge of them is required for verifying conformity with the health and safety requirements.

    Doubt of Conformity

    If the technical file is not presented to the competent national authorities on request this may be sufficient grounds for doubting the machinery’s conformity to the health and safety requirements.

  6. 6
    Step 6 – Issue Declaration of Conformity and place CE mark on the Product
    The CE-marking and the EC Declaration of Conformity

    The EC Declaration of Conformity is a legal statement by the manufacturer or his authorised representative attesting that the machinery concerned complies with all of the relevant provisions of the Machinery Directive.

    The CE marking affixed to the machinery and the manufacturer’s EC Declaration of Conformity that shall accompany the machinery are the first elements that can be checked by the market surveillance authorities.

    In particular, the EC Declaration of Conformity provides essential information to enable the market surveillance authorities to carry out the necessary checks:

    • the identity of manufacturer of the machinery and of his authorised representative, where appropriate;
    • the person authorised to compile the technical file;
    • the conformity assessment procedure that has been followed and the identity of the Notified Body involved, where appropriate;
      the other Directives that have been applied to cover certain hazards more specifically
    • the harmonised standards or other technical specifications that have been applied, where appropriate.

    The CE marking shall consist of the initials ‘CE’ taking the following form:

    If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.

    The manufacturer may choose to affix the CE marking visibly, legibly and indelibly to the toy, to an affixed label or to the packaging.

    The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery.

    The CE marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique.