Here is the scenario: We prepare a product specification. We contract
with an OEM to design and manufacture the product to our
specifications. The manufactured product will be sold in Europe under
our name by our sales representatives. Orders will be shipped
directly to Europe from the OEM. The product is subject to the EMC
Directive and the Low Voltage Directive. We do the EMC Directive
testing (standards route to compliance), the OEM gets the safety
approval.
Question: Who is the responsible party for issuing the declaration of
conformity with the EMC and Low Voltage Directives? I believe that we
are the responsible party because we are still, in a legal sense, the
manufacturer. As the EMC Directive guidelines state: "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 have the appropriate technical file to demonstrate that the product
meets the requirements of the EMC Directive via the standards route
and the OEM has a European safety agency approval which demonstrates
compliance with the Low Voltage Directive. My position is that the
OEM should be authorized by us to apply the CE marking to the product
before shipping to Europe and we, as responsible party, should issue a
declaration of conformity to be held by our representatives in Europe.
Any expert opinions would be appreciated.
______________________________________________________________________
Jim Hulbert Tel: 203-924-3621
Senior Engineer - EMC Fax: 203-924-3352
Pitney Bowes email: [email protected]
P.O. Box 3000
35 Waterview Drive
Shelton, CT 06484-8000 U.S.A.
