No one was anticipating much beyond a boilerplate presentation by European Commissioner for Health John Dalli at the MedTech Forum conference in Brussels and, suffice to say, that expectations were met. The proposed measures offer a “sustainable regulatory framework” to help prevent scandals such as the Pip implant case,” he told attendees on 10 October 2012. The regulation that is now making its way through the European Council and Parliament is “more robust legally, transparent and supportive of innovation” than the directives it will replace, he added.
When quizzed on the scrutiny procedure that is a hotly debated element of the regulation, he conceded that it, in and of itself, “would not have stopped Pip” from happening. Other aspects of the regulation, however, would have had an impact, he noted. Dalli tried to reassure attendees that the scrutiny process would not unreasonably lengthen approval times. “We are talking about days, not years,” he stressed. That prompted medico-legal specialist Erik Vollebregt to tweet that he is making note of that for discussion at a later date.
Dalli expressed absolute confidence that the new regulation will get through the European Parliament before the 2014 elections.Norbert Sparrow