CE Mark Approval, Directives and conformance for R&TTE, EMC, LVD, MIL, E, UL, LVD and Medical

PC SYSTEM BUILDERS

CE marking for system integrations: who’s responsible? what is required? what is CE Mark?
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The end application will define which standards are appropriate for the system.
End users who suspect or knowingly permit a non-compliant system to be installed and used may also fall foul of the Directives and be implicated in any court issues.

So how does an integrator proceed?

Declaration-of-Conformity
Documentation List
EU guide to the Directives

Decide which standards are appropriate to the end product.
Draw up a list of modules and components.
Request Declaration-of-Conformity (D-o-C) from the suppliers.
Check that standards quoted are applicable for your product.
Check D-o-C includes updated amendments for all standards.
Request copies of test reports from the short-listed supplier list.
Verify that D-o-Cs and test reports precisely cover the products.
Study the data very carefully and try to ascertain the implications of combining them together in a single system.
Perform some “snap shot” tests to confirm compliance at an accredited test lab. I tend to favour my own experiences and control which tests are performed and to what depth.
If necessary perform a full formal compliance test to the appropriate standards. This will be expensive and expect to pay an average of £10K.
Now you are in a position to demonstrate “due diligence” and sign the D-o-C.
When placing orders with your suppliers ensure that you include the phrase “supplied equipment must continue to meet the following requirements:” and list the specific standards, on the Contract of Supply.
Assemble the system in a controlled environment. This need not be on your premises but could be at the supplier of the system enclosure.
Apply the CE mark and distribute the system.

Now this process sounds simple enough, and it would be if all module suppliers were diligent in their preparation of test documentation, but the common response is:

“We have never been asked for this before”

Experience has shown that integrators will be embarking on a frustrating and time-consuming paper chase.
Response, if at all, can be after several weeks which leads me to consider that:
1. suppliers who respond with this statement are trying to avoid the extra work involved, or
2. it is a true statement and that I am the only one to request this information.

If 2 above is correct, the implication is that the majority of system integrators are not even applying “lip service” to the requirements of the EU Directives.
This I don’t accept and I would like to hear from others within the industry who have experienced similar responses.

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