Rank: Forum user
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We are installing new manufacturing lines with a number of manufactures supplied equipment. All equipment is individually CE marked by the various suppliers. These manufacturing lines are all interconnected by an overall control system e.g. hit an emergency stop and the manufacturing line will stop. Most of the manufacturing lines are carrying out various intermediate processes including forming, shaping, cooling, coating and finally packaging. Conveyors will also be used within the overall manufacturing line. Some of the lines will use second hand equipment also.
The lines were designed by our own in house engineers and been installed by our own maintenance staff for our own use only.
The manufacturing engineers say they are collating the technical file/information but are not going to CE mark the manufacturing line as they do not think it is required.
I understood that for this type of production line we should assemble the technical file, ensuring it complies with the various regulations (including guarding, noise etc) to ensure it is safe and then CE mark it. Is there any clear guidance on this? If CE marking is required and is not completed what are the implications of this? All advice or experience is appreciated
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Rank: Super forum user
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aiden,
You MUST comply with PUWER98.
As you are putting the line onto the market then you are the importer, designer and manufacturer, thus you must comply with the requirements of the "new approach directives".
If this requires CE marking then this is something you must do or, get a 3rd party to do.
There is no reason at this stage to prepare a "Technical File" under the regulations, however, if your team feel that this is required then CE marking is also required.
All individual items will require either a "Certificate of Incorporation" or a "Declaration of Conformity".
It is good to commence the preparation of the "Technical File" at this stage, so that decisions are recorded and documents are not lost.
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Rank: Super forum user
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Aiden - in order to decide whether your line needs an overall CE mark as opposed to just ensuring the individual components comply with the relevant Machinery Directive (and note that second hand machinery doesn't have to comply retrospectively, only with the legislation that was in place when it was first used in the EEA / EC) you need to consider if it fits the definition of "assembly of machinery"
The Guidance to the Directive (link below) says:
"The definition of assemblies of machinery indicates that assemblies are arranged and
controlled so that they function as an integral whole in order to achieve the same end.
For a group of units of machinery or partly completed machinery to be considered as
an assembly of machinery, all of these criteria must be fulfilled:
− the constituent units are assembled together in order to carry out a common
function, for example, the production of a given product;
− the constituent units are functionally linked in such a way that the operation of
each unit directly affects the operation of other units or of the assembly as a
whole, so that a risk assessment is necessary for the whole assembly;
− the constituent units have a common control system.
A group of machines that are connected to each other but where each machine
functions independently of the others is not considered as an assembly of machinery
in the above sense."
Have a look at Articles 38, 39, 79 in this document http://ec.europa.eu/ente...-42-ec-2nd-201006_en.pdf for more details.
Only you can decide if your line fits the definition. However even if it does you can carry out the conformity assessment and CE marking yourself and it only has to cover the additional risks that are presented by putting the individual machines together, not all the individual risks presented by each component, provided that you have the manufacturers' information on those machines.
The most important thing of course is that your line is in fact safe regardless of documentation and CE marks.
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Rank: Forum user
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Thanks for the advice. It looks like we meet the criteria and that link generally Heather is very good.
Also this could get overly complex if not handled in a pragmatic fashion.
Definitely food for thought.
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