Med-tech industry challenges streamlining of regulations.(International report)

PARIS -- In an odd reversal of roles, the European Commission (EC) has said it will streamline regulations governing medical devices in Europe and seven industry associations immediately organized a staunch opposition to the change.

Even as the most recent modifications to the EC's Medical Device Directives are being put in place by member states of the European Union, the commission unexpectedly launched a call for a consultation on a proposed "recast" of the directives that seemed to catch industry off guard.

Just as the consultation period ended in July, seven trade associations representing 95% of the medical device industry in Europe issued a joint statement saying the system is working just fine and that reopening the regulatory framework at this point "threatens the future competitiveness of our industry."

Industry already knew the EC was considering revisions to address a host of issues arising from emerging technologies, new materials, hybrid drug-device therapies and the thorny problem of single-use devices.

But the swift, unilateral action by the commission and its sweeping scope was completely unexpected.

The EC wants to consolidate its three directives for active implantable devices, medical devices and in vitro diagnostic devices as well as the six subsets of directives that either modified or implemented the three principal directives.

The commission also expressed a concern that some emerging quasi-medical devices are not regulated at a European level, "namely those defined as medical devices consisting exclusively of non viable human cells and/or tissues and/or their derivatives and medical devices."