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FAQ's about the Machinery Directive

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How does a manufacturer choose between the Low Voltage and Machinery Directive?

Answer: Clearly if the equipment does not have any moving parts, then by definition it is not a machine and the LVD will apply alone.  This question often arises when a piece of electrical apparatus is also a machine, or when a machine ie slectrically powered or controlled.  The Machinery Directive article 1.5 requires that where the risks to health and safety are "mainly" of electrical origin, then the machinery is covered "exclusively" by the LVD.  The problem is that this can sometimes be very difficult to judge.  If there is any doubt as to whether the risks are mainly electrical, the Machinery Directive should be applied but the standards used to demonstrate compliance should include an LVD standard, in order to fully and diligently cover the electrical aspects of the machine.  For more infromation on this question, please see the paragraph "Overlap of the Machinery and Low Voltage Directives".

How do the standards relate to the Essential Health & Safety Requirements?

Answer: The EHSRs in the Machinery Directive give broad requirements to ensure the safety of persons, domestic animals and property. They are not technical specifications, in that they do not define any specific design or build requirements, merely the desired results. The Machinery Directive has supporting published harmonized standards the (ENs) which 'confer conformity' with the Directive and these can be used to demonstrate compliance with the EHSRs. Therefore, when these standards are used, there is a presumption of compliance with the EHSRs of the Machinery Directive. It is important to understand that in the Machinery Directive, as in all "New Approach" Directives, it is the EHSRs which must be complied with by law.

What can a Notified Body report provide?

Answer: The Notified Body will examine the product and the supporting documentation such as test results and technical data and give an opinion on the compliance of the product with the EHSRs of the Machinery Directive. Although this report is not mandatory and the manufacturer is at liberty to self-certify without such a report, there may be circumstances, for example where ENs or other standards have not been applied, when it would be prudent for the manufacturer to seek such a professional second opinion, in order to have a higher degree of confidence in the safety of the product and to demonstrate due diligence.

Is testing in the US allowed to prove EU compliance?

Answer: Yes, as long as it can be shown if required that the necessary tests and evaluations have been properly identified and carried out.

Can I add other safety marks to the product if I have the CE Marking?

Answer: Other marks may be applied to the product to indicate safety standards have been complied as long as these marks do not obscure or become confused with the CE Marking.  Although the amending Directive 93/68/EEC will remove the need to have safety marks from certification bodies as a way of showing legal compliance, it does not preclude the continued use of these marks. Often it is a customer or contractural requirement that such marks are on the product and these cases where it is felt that a commercial disadvantage may accrue from dropping the marks, they will be retained. They do not signify the same things as the CE Marking.

How do I know what standards to apply to my product?

Answer: Seek advice from a consultant, test laboratory, Notified Body or the Official Journal.

What does the "responsible person" have to do for a Technical File?

Answer: Here are some differences between the Machinery Directive and the LVD.  For Machinery, the responsible person can be the manufacturer outside the EU, the authorized representative inside the EU or the user (importer) of the machine. The RP must be able to assemble the file on demand by the authorities.  It does not need to be complete.

 

 

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