Barco MDRC-2124 specification

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 and—by itself—no medical utility, the display is classified according to Rule 12 as an MDD Class I device, component, or accessory. The MDD states that manufacturers of Class I medical devices or accessories shall satisfy the requirements in regard to design and manufacturing controls, that is, the applicable assessment route to be used for CE-marking under the MDD, and it shall carry the CE mark according to Annex XII of the directive, with no notified body annotation.

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 flat-panel display meets the essential health and safety requirements, is in conformity with, and the CE marking has been applied according to the relevant EU Directives listed below, using the relevant section of the following EU standards and other normative documents;