CE marking for the package components

[vjr0512]

For one of the Package , purchased from Europe, CE marking is a Must as per European Directives and vendor has agreed to provide the same. But vendor has said that the Individual itmes say manually operated valves, that are installed inside the package need not be certified for CE marking since the whole package is CE marked. Actually vendor had not purchased the valves with CE marking .

But the Inspector is challenging that CE marking has to be done for each and every item inside the package. Which argument is correct?

 

[ornerynorsk]

The particular standard(s) which covers that industry or line of items will have direction on labeling. I am only familiar with class I medical for Europe, and labeling attached to the product itself must bear the CE mark.

It is better to have enough ideas for some of them to be wrong, than to be always right by having no ideas at all.

 

[micalbrch]

Refrain from double posting! To ask the question in one forum is enough.

 

[HPost]

If you have purchased a proprietary item from a 3rd party vendor, to be compliant, it must have a certificate of conformity. That being the case, you are covered in terms of providing a C of C for the whole system. You just need to keep the C of C from the 3rd party supplier in the technical file for the project. Then, if there is an audit, you can demonstrate compliance. In effect, you cannot complete the mandatory risk assessment with having the necessary C of C for each of the internal components and assemblies.

If you have manufactured the internal components, then you will need to provide a C of C for the product and that will involve going through each of the 6 steps. If the valve has a working pressure in excess of 0.5BAR differential pressure, then it need to conform to the pressure equipment directive and also the machinery directive.

In effect, you cannot CE mark the whole system unless you can complete a good risk assessment against all of the internal components. If the internal components are not CE marked, then you cannot complete the risk assessment.

The PUWER regulations dictate that any machinery must be compliant. If you cannot be assured of compliance, don't accept the package.

Your inspector is correct.

 

[ivymike]

You didn't mention whether these valves are covered by the Pressure Equipment Directive or ATEX. If neither, then the valves are probably considered components of a machine (covered by Machinery Safety Directive). Components of a machine don't need to be CE marked if they come with a Declaration of Incorporation (DOI) and cannot work by themselves as a machine.

http://www.hse.gov.uk/work-equipment-machinery/declaration-incorporation.htm

"partly completed machinery is not in a final state that will allow it to operate and it needs to be incorporated with other parts so it can work as part of the final machine."
"If a product can operate as a machine it must always be fully protected with all safeguards provided, be CE marked and accompanied by a Declaration of Conformity."

 

[JohnGP]

Much speculation here. As micalbrch hints at, it would be prefereable to continue any discussion/clarification in the posting in the CEN / ECN (eu standards) forum, where a bit more info was presented.

 

[bobbyyan]

The vendor is correct in this case.