LVD or MACHINERY Directive, in certain cases Machinery Directive may require NOTIFIED Body

Administrative provisions The administrative provisions of the Directive (at least so far as manufacturers are concerned) are primarily aimed at forcing manufacturers 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. Relationship with the Low Voltage Directive The Machinery Directive is mutually exclusive with the Low Voltage Directive, so that either one or the other will apply but never both. Annex 1 of the Machinery Directive contains requirements for electrical safety which precisely mirror those of the LVD, so the safety requirements of the two directives are identical, but the Declaration of Conformity will cite the Machinery Directive and not the LVD. Annex IV machines As mentioned in the previous section, the vast majority of machinery may be self-certified by the manufacturer (or their authorised representative within the EU). However, this is not the case for Annex IV machines. Annex IV of the Directive contains a list of about 25 types of machine which are subject to special procedures. Machines in this list must either be made fully in accordance with the provision of the relevant type C standard, or they must be subject to a type examination by a Notified Body. Safety components Safety components are equipment which are independently placed on the market and whose failure might endanger the safety of persons. The Directive includes an indicative list (Annex V). Items on this list include: Guards for PTO shafts PLC’s used to control safety related functions Monitored hydraulic valves Load monitoring devices for lifting machinery Emergency stop controllers and two hand control relays Safety equipment intended to fit on machinery for lifting people It's notable that many of these items do not fit the traditional definition of machinery and might more normally be considered as electrical equipment. However, because they have a safety function for machinery they are covered by the Machinery Directive and hence excluded from the LVD. Declaration of Incorporation The application of the CE mark under the Machinery Directive is in effect a statement which confirms that the machinery fully complies with the requirements of the Directive and is safe to use. Clearly, this is not appropriate for partly completed machines which are intended to be incorporated into another machine or which cannot function unless they are built into a complete production line. For these circumstances, instead of signing a Declaration of Conformity, the manufacturer does what they can to assess the machine they have built and to mitigate any risks to the user, and then signs a document called a 'Declaration of Incorporation'. This basically states that the machinery is incomplete and must be made to fully conform with the requirements of the Directive before it is brought into service. The manufacturer must provide information on the residual risks which the machine contains and on the assessment work which they have completed. The Declaration of Incorporation is a concept which exists only in the Machinery Directive and so if other CE marking directives apply (e.g. a check-weigher which is intended for incorporation into a packaging line, and which is covered by the EMC and ATEX directives as well as being a machine) then the machinery must carry the CE mark for these directives even though it is not CE marked as a machine. Future developments Although it is not yet in force, the Commission are already lining up an amendment to the Directive. This will introduce a new requirement for environmental protection for equipment used for the application of pesticides and herbicides. Other directives affecting machinery Apart from the EMC and Low Voltage Directives already mentioned, other directives which are likely to have an effect on equipment within the scope of the Machinery Directive are Directive 2000/14/EC on the noise emission of equipment intended for use outdoors, and Directive 2002/44/EC on human body exposure to vibration ('the Physical Agents Directive'). The latter directive sets limits for the maximum exposure of workers to hand-arm and whole body vibration in the workplace and so goes much further than the basic essential requirements of the Machinery Directive. It is entirely conceivable that some machinery can be legitimately CE marked under the Machinery Directive but for it to be basically useless in the work place because it exposes the user to excessive vibration levels when in use. For machinery intended for use in a flammable atmosphere, the ATEX Directive will apply, and engine driven machinery is likely to be subject to the Non-road mobile Engine Exhaust Emissions Directive. Additionally, the RoHS and WEEE directives may apply to machines which also contain electrical equipment. Useful links The European Commission have a special section on machinery with a great deal of useful information on their EUROPA server. This includes the full text of the directive, lists of the currentharmonised standards as well as guidance and interpretative documents. For details of draft standards, the New Approach web site is a good EU-funded resource. The UK government's Department of Business, Innovation and Skills (BIS) publish a number of useful guides on the Directive and these are available for download. Useful information may also be found on the Health and Safety Executive web site. Information about bodies notified under the Directive can be found on our Notified Bodies page and from the European Commission's NANDO database. Further advice As with all CE marking directives, the actual requirements for any piece of equipment under the directive are complex and dependent on not only the design but also the type of user, the intended use and sometimes even what is claimed in the instructions or sales literature. For further advice specific to your products, please contact us at Conformance and we will bepleased to discuss your needs. If you'd like us to prepare a no-obligation quote for assisting you with CE marking your products, please take a look at our page which gives details of the information required in order to be able to give you an accurate idea of the costs and procedures involved.

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Annex IV machines As mentioned in the previous section, the vast majority of machinery may be self-certified by the manufacturer (or their authorised representative within the EU). However, this is not the case for Annex IV machines. Annex IV of the Directive contains a list of about 25 types of machine which are subject to special procedures. Machines in this list must either be made fully in accordance with the provision of the relevant type C standard, or they must be subject to a type examination by a Notified Body. Safety components Safety components are equipment which are independently placed on the market and whose failure might endanger the safety of persons. The Directive includes an indicative list (Annex V). Items on this list include: Guards for PTO shafts PLC’s used to control safety related functions Monitored hydraulic valves Load monitoring devices for lifting machinery Emergency stop controllers and two hand control relays Safety equipment intended to fit on machinery for lifting people It's notable that many of these items do not fit the traditional definition of machinery and might more normally be considered as electrical equipment. However, because they have a safety function for machinery they are covered by the Machinery Directive and hence excluded from the LVD. Declaration of Incorporation The application of the CE mark under the Machinery Directive is in effect a statement which confirms that the machinery fully complies with the requirements of the Directive and is safe to use. Clearly, this is not appropriate for partly completed machines which are intended to be incorporated into another machine or which cannot function unless they are built into a complete production line. For these circumstances, instead of signing a Declaration of Conformity, the manufacturer does what they can to assess the machine they have built and to mitigate any risks to the user, and then signs a document called a 'Declaration of Incorporation'. This basically states that the machinery is incomplete and must be made to fully conform with the requirements of the Directive before it is brought into service. The manufacturer must provide information on the residual risks which the machine contains and on the assessment work which they have completed. The Declaration of Incorporation is a concept which exists only in the Machinery Directive and so if other CE marking directives apply (e.g. a check-weigher which is intended for incorporation into a packaging line, and which is covered by the EMC and ATEX directives as well as being a machine) then the machinery must carry the CE mark for these directives even though it is not CE marked as a machine. Future developments Although it is not yet in force, the Commission are already lining up an amendment to the Directive. This will introduce a new requirement for environmental protection for equipment used for the application of pesticides and herbicides. Other directives affecting machinery Apart from the EMC and Low Voltage Directives already mentioned, other directives which are likely to have an effect on equipment within the scope of the Machinery Directive are Directive 2000/14/EC on the noise emission of equipment intended for use outdoors, and Directive 2002/44/EC on human body exposure to vibration ('the Physical Agents Directive'). The latter directive sets limits for the maximum exposure of workers to hand-arm and whole body vibration in the workplace and so goes much further than the basic essential requirements of the Machinery Directive. It is entirely conceivable that some machinery can be legitimately CE marked under the Machinery Directive but for it to be basically useless in the work place because it exposes the user to excessive vibration levels when in use. For machinery intended for use in a flammable atmosphere, the ATEX Directive will apply, and engine driven machinery is likely to be subject to the Non-road mobile Engine Exhaust Emissions Directive. Additionally, the RoHS and WEEE directives may apply to machines which also contain electrical equipment. Useful links The European Commission have a special section on machinery with a great deal of useful information on their EUROPA server. This includes the full text of the directive, lists of the currentharmonised standards as well as guidance and interpretative documents. For details of draft standards, the New Approach web site is a good EU-funded resource. The UK government's Department of Business, Innovation and Skills (BIS) publish a number of useful guides on the Directive and these are available for download. Useful information may also be found on the Health and Safety Executive web site. Information about bodies notified under the Directive can be found on our Notified Bodies page and from the European Commission's NANDO database. Further advice As with all CE marking directives, the actual requirements for any piece of equipment under the directive are complex and dependent on not only the design but also the type of user, the intended use and sometimes even what is claimed in the instructions or sales literature. For further advice specific to your products, please contact us at Conformance and we will bepleased to discuss your needs. If you'd like us to prepare a no-obligation quote for assisting you with CE marking your products, please take a look at our page which gives details of the information required in order to be able to give you an accurate idea of the costs and procedures involved.
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			Contents: Purpose Scope Off-road vehicles Directive history Enforcement Penalties Requirements Relationship with Low Voltage Directive Annex IV machines Safety Components Declaration of Incorporation Future developments Other directives affecting machinery Useful links Further info Full Text Download See also: Self built equipment Off-road machinery web page DOC-EUPOINT service for non-EU based manufacturers

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