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, […]
Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no change compared to the last version that was available among stakeholders. For that reason, I will not repeat all […]
Netherlands-based medical devices legal specialist Erik Vollebregt speaks to Ashley Yeo about how the European database of medical devices is faring. The European database of medical devices, Eudamed, is showing its potential to strengthen market surv…
Netherlands-based medical devices legal specialist Erik Vollebregt speaks to Ashley Yeo about how the European database of medical devices is faring.The European database of medical devices,Eudamed, is showing its potential to strengthen market survei…