Circle 10 July 2013 on your calendar. That is when a European Parliament committee will vote on a report calling for a new premarket authorisation (PMA) system for implantable devices, including randomised clinical trials. The stakes are enormous, according to Eucomed chairman Guy Lebeau, who told Reuters that overreach in EU medical device regulations would destroy one of the last industries where the level of start-ups is among the best in world.
Rapporteur Dagmar Roth-Behrendt, who chairs the EU committee where this proposal is under discussion, is lobbying for stricter medical device regulations. If her report is endorsed, it will go to a full plenary vote in parliament in the autumn and inform final discussions between governments, reports Reuters.
As reported in medtechinsider last month, the likelihood that a PMA-style system will be approved is fairly remote. But even a faint possibility that it will pass has industry on edge.
Since 2007, venture firms have invested in more than 1500 small and medium-sized medical device companies in Europe, creating medtech hot-spots in Britain, Germany, France and the Nordic countries, reports Reuters. Antoine Papiernik, managing director of venture capital firm Sofinnova, told Reuters that investors had been putting their money in Europe because it offered a more predictable environment than the United States. That comparative advantage would be lost, and investment would be slashed, if the new rules were to go through.
Eucomed has been raising awareness of the consequences of a more-burdensome regulatory environment with its “Don’t Lose the 3” campaign, a reference to the fact that many medical devices are placed on the market in Europe, on average, three to five years sooner than in the United States.
The notorious Pip implant scandal has fueled the drive for stricter regulatory oversight on high-risk devices. Eucomed and members of industry have noted, however, that the breast implant scandal was a case of fraud, pure and simple, and that there is no evidence to suggest that instituting a PMA-style system would improve patient safety.