Jun 7, 2011

The European Union’s Employment, Social Policy, Health and Consumer Affairs Council has issued Council Conclusions supporting the existing legal framework for medical device and technology regulation and emphasizing the importance of device innovation in maintaining a viable health care system in the EU.

According to a Eucomed press release, the council’s announcement paves the way for the full integration of medical technology innovation into EU health care policies by the European Commission. The council’s position furthermore advocates tactical adjustments to the current European regulatory system for medical devices rather than wholesale changes, according to the trade association.

The council’s conclusions also contain recommendations for the European Commission’s consideration as it reviews the current Medical Device Directives:

  • A new system should be sustainable, ensure public safety and promote innovation
  • Differences between CE Marking and health technology assessments should be recognized in terms of when they happen and how clinical evidence is used in each of these processes
  • Notified bodies should be “improved”
  • Vigilance should be more coordinated and coherent
  • A more advanced, centralized IT infrastructure should be established and accessible to the public
  • Transparency of the European regulatory system should increase


  • Stewart Eisenhart