As EC Seeks Another MDD Recast, Device Industry Urges Caution

Devicemakers on both sides of the Atlantic are urging restraint as the European Commission (EC) proposes another round of changes to the EU’s Medical Device Directives (MDD). “We pointed out to the EC that they should allow the recent changes to take effect and then evaluate the impact of those changes,” Ralph Ives, AdvaMed’s vice president of global strategy and analysis, said. But the EC’s response has been that the previous changes, which went into effect last March, do not address its key concerns, “which is the different levels of expertise among the notified bodies in Europe and need for greater consistency,” Ives said.
International Medical Device Regulatory Monitor