Addressing the PIP situation with heightened regulatory controls is playing to the crowd, especially when most of the new rules relate less to one act of fraud than they do ostensibly to innovation in the interests of patients.
Medical Device Regulation in Europe is changing. Today’s press conference should highlight the main points
As we’ve already noted, today’s the day when the EU commission announced the results of its lengthy rehash and consultations of the medical devices directive.
Today is indeed the day on which we welcome the adoption of a new set of medical device regulations, to become law from 2015. It’s about time too in our view because the credibility of the current EU set-up has been damaged by public dissection following a number of high profile product problems.