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Product Certification

    Machinery Directive

    Summary

    The Machinery Directive (MD) is the core European legislation regulating mechanical engineering products. In the Directive, machinery is described as "an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application". The current Machinery Directive (2006/42/EC) has been in force since 29 December 2009.

    The Machinery Directive provides the regulatory basis for the harmonisation of the essential health and safety requirements applicable to machinery at EU level. Before placing a machine on the EU market, the manufacturer has to drew up a technical file and to ensure that his machinery complies with the Directive through an assessment process. Afterwards, the manufacturer or his authorised representative has to draw up a Declaration of Conformity (or a Declaration of Incorporation for partially completed equipment). After CE marking the product, the machinery may be placed on the market.

     

    Scope

    The Directive applies to all machinery and to safety components. A machine is defined as “an assembly … of linked parts or components, at least one of which moves…”. Clearly this definition encompasses a very large range of machines, from simple hand-held power tools through to complete automated industrial production lines.

    There are some exclusions from the Directive - for example motor vehicles used on public roads, weapons and machines which are already covered by other, more specific, directives (e.g. lifts and Toy Safety Directive). It is also possible for the Machinery Directive to apply alongside other directives when there are hazards which the more specific directive does not fully cover, for example the lifting function of medical devices used to move patients. Certain specific types of equipment which fit the definition of machinery but are also within the scope of the Low Voltage Directive are also excluded from the Machinery Directive on the grounds that the risks they present are mainly electrical in nature. These include “ordinary office machinery” and “household appliances for domestic use”.

    Secondhand machinery which was first used within the EEA prior to the date of the implementation of the old directive (i.e. before 1 January 1995) is excluded from having to comply with new Directive. However, if that machinery is refurbished or upgraded so that its original specification is changed, it will have to be made to comply with the full requirements of the Directive.

    Any machinery which was manufactured before 1 January 1995 must be made to comply with the directive if it subsequently brought into Europe from outside just as would any newer machinery manufactured outside the EU.

    Equipment manufactured for the manufacturer's own use is not excluded from the requirements, but may be subject to slightly lesser obligations with respect to marking and documentation.

     

    Requirements

    The vast majority of machinery may be self-certified by the manufacturer (or their authorised representative within the EU). What this means is that so long as the administrative and safety requirements of the Directive are properly satisfied, the manufacturer can perform all of the assessment and documentation procedures in-house and does not need to submit to any form of external test or approval.

    The requirements of the Directive can essentially be split into two sections - the 'essential health and safety requirements' and administrative provisions.

    • Essential health and safety requirements

    The essential health and safety requirements demand that machine manufacturers identify the hazards which their products contain and then assess the risks which these hazards present to users. Any risks thus identified must be reduced to as low a level as is reasonably practicable.

    Annex I of the Directive gives a comprehensive list of the potential hazards which may arise from the design and operation of machinery, and gives general instructions on what hazards must be avoided. Detailed requirements are laid out in a series of safety standards.

    The standards are drafted by multi-national committees of industry experts and reflect design requirements for particular pieces of machinery much more closely than could ever be achieved by specific legislation. Once a standard has been accepted by the European Commission (the process of 'harmonisation'), it is given the 'EN' prefix. This means conformity with the requirements of the standard gives a 'presumption of conformity' with the requirements of the Directive.

    Because so many standards are required to cover the full range of machines within the scope of the Directive, the European standards bodies devised a hierarchy which can be applied in every situation. The most basic standards, known as 'Type A' standards set out requirements for the safety of machines only in the most general terms: indeed part 2 of EN ISO 12100 is essentially a reproduction of annex 1 of the Machinery Directive. 'Type B' standards deal with more specific issues: design of emergency stops (EN ISO 13850); prevention of unexpected start-up (EN 1037); pneumatic systems (EN ISO 4414); temperature of touchable surfaces (EN ISO 13732-1) and many others. Finally, 'Type C' standards deal with specific types of machine: for example, EN 1012 deals with safety of compressors and vacuum pumps; EN 792 deals with pneumatic hand tools and EN 201 deals with injection moulding machines for rubber or plastic.

    •  Administrative provisions

    The administrative provisions of the Directive (at least so far as manufacturers are concerned) are primarily aimed at forcing manufactures to provide documentary evidence that the machinery complies with the Directive. This is done via the creation of a 'Technical File'. The general form and content of the Technical File is dictated in the Directive and manufacturers must be able to make this information available for inspection by the authorities (the HSE in the UK) for up to 10 years after the date on which the machine was sold. However, except for Annex IV machines (see below), there is no obligation to produce a copy of the file unless demanded to do so by the enforcement authority, and only the enforcement authority has a right to see it. The manufacturer does not have to provide a copy to the customer unless they choose to.

    Machinery meeting the requirements of the Directive is required to have the CE logo clearly affixed to indicate compliance. It must also show the year of manufacture, some form of serial number, and other ratings as required by the relevant standards. An item of equipment may only display the CE mark when the equipment satisfies all relevant directives; for instance machines with electrical controls must also comply with the requirements of the EMC Directive.

    Where volume production is envisaged, the Directive requires that control measures must be implemented to ensure that all of the machines manufactured will conform to the provisions of the Directive.

    Finally, the manufacturer must prepare and sign an 'EC Declaration of Conformity'. This is basically a statement which confirms the identity of the manufacturer and the machinery for which they are claiming compliance, and is signed to confirm that the correct procedures have been followed. If the manufacturer is based outside the European Community, this Declaration must also contain the address of someone within the EU from whom the authorities can obtain the technical documentation.