Regulatory Compliance | 23
In summary, NDS Surgical Imaging is CE-marking these displays under the
Medical Device Directive, which establishes compliance to the basic medical
safety standards. However, EMC compliance can only be accomplished in the
configured medical device or system and is the responsibility of the device or
system manufacturer. NDSsi has the necessary documentation such as IEC
60601-1 notified body and other third-party test reports and certifications,
a risk/hazard analysis, an essential requirements checklist, and the NDS
Surgical Imaging International Electrotechnical Commission (IEC) declaration
of conformity.
NDS Surgical Imaging, located in San Jose, Calif., USA, is the manufacturer of
these displays in the meaning of the directive. As required by the MDD in
Article 14, NDS Surgical Imaging, not residing in the European Economic
Area (EEA), has a European representative, NDS Surgical Imaging —
Nijverheidscentrum 28, 2761 JP Zevenhuizen, The Netherlands (phone
+31-180-63-43-56; fax +31-180-63-21-91).
In the opinion of NDS Surgical Imaging registration required to put this
device into commerce is the responsibility of the medical device/system
manufacturer, and NDS Surgical Imaging supports this requirement by
providing a European Commission (EC) declaration of conformity. If NDS
Surgical Imaging 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, NDS Surgical
Imaging will provide any information requested by competent authority to
support any reported incident investigation by such an authority.
