The display was classified as required by the MDD according to Annex IX of the directive and the medical device (MEDDEV) guidance available at the time of classification. Because the display uses electrical energy and has no direct patient connections
In the opinion of Barco NV registration required to put this device into commerce is the responsibility of the medical device/system manufacturer, and Barco supports this requirement by providing a European Commission (EC) declaration of conformity. If Barco 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, Barco NV will provide any information requested by competent authority to support any reported incident investigation by such an authority.
EU Declaration of Conformity for Medical Application
A Declaration of Conformity has been filed for this product. For additional copies of the Declaration of Conformity document, contact Barco NV
The MDRC series digital
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