Thank you all who responded to this thread.

All inputs I got are generally in agreement, and in line with my opinions.
Here are the conclusions. They are mainly applicable to custom design, but
also extend to COTS equipment available on the market.

1. It is not relevant if subcontracted parts are CE marked or not. What's
important is that they are compliant with the standards applicable to the
end-product. We, as an integrator of the end-product, have to identify those
standards and/or parts of them that are relevant to the purchased component.

2. The requested documentation shall be relevant for the public law (EU
Directives/CE Marking) and the civil law (liability issues).

3. The needed documentation, for CE marking (under the public law), as we
follow the TCF and/or the Standards route under various Directives, will
consist of full copies of test reports/technical analysis/technical
descriptions if the manufacturer is able to do all of these (audits might be
required). If not, certificates from accredited labs are mandatory, and
copies of test reports are needed if possible.

4. To cover eventual liability issues (civil law), the product integrator
shall request a private compatibility statement (listing the suitable
standards, product detailed description), and completed with additional
purchase requirements, such as not allowing modification of the part in such
a way that it might impact the compliance of the end product (or at least
not allow to do that without notice).

Alexandru Guidea
CAE Inc.
Montreal, CANADA




>>>>Our company purchases power distribution equipment designed per our
specs.
This equipment is not put on the market, but integrated in our products, and
does safety/EMC functions(EMI filtering, protection, emergency stop) among
other things, in accordance to the EC Directives applicable to our product.
We believe there is no point to have it CE marked but only compliant with
the standards we need. The text of the EMC Directive reads "the manufacturer
may subcontract certain operations, e.g., apparatus design or production,
provided that he retains overall control and responsibility for the
apparatus as a whole. By the same token, he may use ready-made items or
components, CE marked or not, to produce the apparatus without losing his
status as a manufacturer."

We follow the Technical Construction File route for CE marking.  What's the
documentation required from our sub-contractors that proves compliance with
the EN standards we indicate? Do we need complete copies of test reports,
technical description, analysis, or just a statement of compliance would do
the job? What's the legal value of such a paper in North-America? As we
don't control their production (parts, quality, etc,) what's the
documentation we shall request to ensure all production units are compliant?
What's the industry/your practice in this case?>>







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