Holding the Technical File

Machinery Directive 2006/42/EC came into force on December 29th 2009 and with it, came a number of changes which impact machine builders greatly. One of these changes is a new requirement that a manufacturer based outside the EU must appoint a person based in the EU, to be responsible for providing the technical file to the national authorities if so requested.

This person may also, but does not have to, be an authorised representative – the key point is that such a person does not have to actually draw up or produce the technical file, only to be responsible for providing authorities with access to it. Any individual or company based in the EU could offer this service. Once appointed, the name and address of this person established within the EU, must be included on the Declaration of Conformity.

This greatly impacts on non-EU machine builders who have previously self-certified their equipment. Whilst they can still self-certify, they will now need to establish a link with a European company or individual before selling their equipment into the EU.

Laicon can offer a comprehensive technical construction file holding service for the new machinery directive which can be tailored to the individual company requirements.

There are two main options for the Technical Construction file holding service. These are:

  1. One off machinery

For $2,000.00, Laicon will hold the Technical Construction File within Europe for a period of ten years and make it available for inspection if required by national authorities.

  1. Series manufacture

Where machinery undergoes series manufacture, Laicon will hold the Technical Construction File and review it annually to ensure compliance with relevant EN standards. The cost for this service will be determined on a case by case basis as it is dependent on the complexity of the machinery.