Jan 17, 2013

The German Medical Technology Association (BVMed), Germany's largest medical device industry trade group, has urged "immediate" implementation of legal measures by the European Commission to boost surveillance of Notified Bodies as well as market surveillance of medical devices.

BVMed argues that three proposals in the new Medical Devices Regulation legislation should be extracted and launched this year:

  • Harmonization of designation and surveillance practices of Notified Bodies
  • Harmonization and improvement of market and manufacturer surveillance done by Notified Bodies and Competent Authorities
  • Centralized registration of manufacturers and vigilance reporting using the Eudamed database

According to BVMed CEO Joachim Schmitt, fast-track implementation of these processes would help rebuild confidence in the EU regulatory approval system for medical devices following the PIP breast implant scandal raised questions about European device review practices.

As previously reported by Emergo Group, the European Commission has already drafted its so-called "PIP Action Plan" that would increase regulatory oversight of Notified Bodies; the plan could be implemented as early as 2013, well ahead of broader draft regulations and within the timeframe advocated by BVMed.