Hi All,
EU has released a revised MEDDEV Guidance document for Vigilance System
2.12-1 rev.8.
"Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013."
Regards,
Sreenu
EU has released a revised MEDDEV Guidance document for Vigilance System
2.12-1 rev.8.
"Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013."
Regards,
Sreenu
Attachments
-
663.5 KB Views: 404