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Engineering Education, Resources and Standards
News Release from: TUV Rheinland UK
Edited by the Engineeringtalk Editorial
Team on 18 February 2003
Modifications to Machinery Directive
Machinery to be sold in the European Union must comply with the Machinery Directive.
Machinery to be sold in the European Union must comply with the Machinery Directive Compliance is often based on a self-declaration by the "responsible person"
This article was originally published on Engineeringtalk on 22 Jan 2002 at 8.00am (UK)
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However, machinery with particular hazards classified under Annex IV of the Directive, requires the involvement of a Notified Body and, at minimum, the submission of the technical file (TF) to the Notified Body (NB) for storage purposes.
Annex IV Machinery, once modified and returned to the market, must also comply with the Directive and be re-approved by the NB again.
To avoid shopping around until approval is found, Notified Body rules forbid the "responsible person" applying to multiple NBs with the same machine.
Guidance issued by EU Notified Bodies requires all modifications to be assessed by the original Notified Body, whether the responsible person has changed or not.
This guidance is to prevent situations occurring where the modifying party, in effect, becomes the new "responsible person" but without any rights of access to the original TF.
Application, if then made to a second NB, would prevent further involvement by the most qualified organisation (the original NB) for assessment of the modifications and possibly lead to an inability of the second to approve the machinery to be certified due simply to a lack of information.
The machinery may then lay idle until either declared unsafe due to lack of technical information or approved if and when sufficient information becomes available.
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