Evangeline Loh and Stewart Eisenhart The European Union’s long-anticipated revision of its

Evangeline Loh and Stewart Eisenhart

The European Union’s long-anticipated revision of its Medical Device Directives has prompted considerable speculation among industry participants and observers—naturally, given the lack of final details thus far. But EU commissioners recently have provided more substantial clues as to what the revision will entail and how it will work—and itlikely will not be a recast.

Most recently, Jacqueline Minor, director of Consumer Affairs at the European Commission’s Health and Consumer Policy division, presented a “recast” update at the annual Regulatory Affairs Professional Society (RAPS) conference held inIndianapolis, Ind., on Oct. 24. The material corroborated information recently presented in other venues.

Emphasizing that the revision is intended to bolster the EU’s existing regulatory system, Minor said that amending that system would enable better support of innovation, more rapid access to market for device manufacturers as well as balance between pre- and post-market controls and cost effectiveness. Although the revision identifies and targets weaknesses in the current system, Minor pointed out that 80 percent of European manufacturers are small to medium-sized enterprises (SMEs); any revisions to the EU regulatory system, therefore, must ensure minimum negative impact on the industry.