AdvaMed and Eucomed Meet to Discuss Proposed Changes to Medical Devices Directives by the European Commission

During the first day, discussions focused on two major issues the EC has identified as particularly important - improved management of the regulatory system among the EC's 27 member states, and the EC's view that there is a need for enhanced pre-market review of high-risk innovative technologies. On the second day, representatives from five of Europe's notified bodies, which are authorized by European countries to evaluate medical devices for CE marking, presented their views on ways the system could be strengthened.

“Members of AdvaMed and Eucomed share a strong conviction that the European regulatory system should be maintained,” said Ralph Ives, executive vice president of global strategy and analysis at AdvaMed. “We have studies that prove the European system is just as safe as the FDA and provides patients innovative therapies many months in advance of FDA approvals. We also recognize that the system can be improved, such as having more consistency and better management of the decentralized notified body system.”

AdvaMed and Eucomed plan to continue to coordinate positions to present to the EC for its impact assessment of possible revisions, which is expected to be completed during the first half of 2011. “The EC has welcomed AdvaMed input. We want to present recommendations for improved consistency in the regulatory system across the European Union that reflect a united industry,” Ives concluded.