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,
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.
