Barco MDRC Series, Руководство пользователя

Страница: 46 / 55

46
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;