I have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that started a train of thought on how these cases might influence the medical devices industry, especially because I have already mentioned that these […]
Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or revision of the EU medical devices directives, however you want to call it in the mean time. I believe the term ‘revision’ is […]
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, […]