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.
No comments:
Post a Comment