New EU guidance on medical devices vigilance reporting – more than meets the eye

The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7. It is clear that the EU is upping its game on vigilance with the ongoing criticism on the CE system for medical devices, whether warranted or not, in mind. If you ask me, I think the system is good on paper but the execution can be much improved. We will have to see where the currently ongoing revision takes us. S [...] « Read the rest of this article on medicaldeviceslegal »