Europe may be on the cusp of a big drive toward a more clearly organized and more transparent postmarket vigilance system with new funds directed at the issue in the wake of device safety scandals. The European Commission recently launched the second phase of its joint action plan of near-term device and diagnostics reforms, pushing postmarket surveillance to the top of its agenda.

As US medical device regulations moderate and EU regulations start to become more stringent, companies have a harder decision to make about which of the two markets they should target for initial launch of their products, says Thierry Chignon, senior partner at Mérieux Développement.

Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.