“Compared with pharma, we are cowboys” I was told a couple of years ago from a medical device manufacturer. “We shoot from the hip”. This was in one of my first medical device assignments. At the same time a change towards “more pharma like” vigilance regulations were anticipated since years and now the deal was reached on new EU rules May 25. (Press Release EU consilium Medical Devices). This is also evident from education providers that launch new Device Vigilance courses where previously only pharmacovigilance was present.
TaRes stays updated via the DIA network . Interestingly enough the organisation recently changed its name from Drug Information Association to Develop. Innovate. Advance. This nicely displays its extension from “pharmaceuticals” to “health care products”.