Planar Systems, Inc., located in Beaverton, Oregon, USA, is the manufacturer
of these displays in the meaning of the directive. As required by the MDD in
Article 14, Planar Systems, Inc., not residing in the European Economic Area
(EEA), has a European representative, Planar Systems, Inc.—Olarinluoma 9,
P. O. Box 46, FIN-02201 Espoo, Finland (phone + 358 9 420 01;
fax + 358 9 420 0200).
In the opinion of Planar Systems, Inc. registration required to put this
device into commerce is the responsibility of the medical device/system
manufacturer, and Planar supports this requirement by providing a European
Commission (EC) declaration of conformity. If Planar supplies a display to an
end user, rather than a device manufacturer, it is the end user’s responsibility
to ensure continued compliance with the MDD of the system in which the
display is integrated.
The supplier will make available on request, circuit diagrams, component part
lists, etc.
For vigilance reporting as required under Article 10 of the MDD, Planar
Systems, Inc. will provide any information requested by competent authority
to support any reported incident investigation by such an authority.