Revision 8 of MEDDEV 2.12-1, the new European Medical Device Vigilance Guidelines, will replace the current version on July, 2013. It may lead you to update your vigilance procedure.
The main addition in this new guideline version concerns the In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products which are now explicitly included within the scope of the vigilance system. Additional notes are related to the “Indirect harm” concept.
