Revision 8 of MEDDEV 2.12-1, Guidelines on a Medical Device Vigilance System, was released in January 2013, which will be applicable as from July 2013.
This revision's 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.'
A copy of this revision can be downloaded here.
Showing posts with label Medical Device Vigilance System. Show all posts
Showing posts with label Medical Device Vigilance System. Show all posts
04 February, 2013
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