Directives usually address broad product families, as is easily understood from their titles:
– Directive 2006/42/EC Machineries
– Directive 2006/95/EC Low Voltage Material
– Directive 2004/108/EC Electromagnetic compatibility (EMC).
They also address a number of other products, such as Gas appliances, Pressure Equipment and Devices and, on existing Directives there is a continuous updating and tuning.
For each product the company must identify applicable Directives and prepare the Technical File, to be kept available for surveillance Authorities; in this documentation together with basic information such as:
– identification of manufacturer (or of the subject placing the product on the market)
– product description and intended use
we assemble documents such as:
– Specifications / drawings / schemes, according to what needed
– Software documentation if any
– Results of type testing / product qualification studies / certification
– Manufacturing procedures and instructions
– Use, installation and maintenance instructions.
The criterion to be used in this work comes out from the risk analysis, generally carried out according to applicable EN technical standards.
European Authorities assigns a great value to the operator responsibility; the subject placing the product on te market can usually proceed preparing the Technical File under his responsibility; in most critical cases the intervention of a technical inspection body (Notified Body) is required.