Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.

Why Should You Attend:

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The training will be discussing the recently implemented and currently planned changes to the Medical Device Directives across the EU.

Areas Covered in the Seminar:

• The current regulatory situation in relation to Medical Devices in the EU.
• The purpose of the Medical Device Directives.
• Meeting the New Requirements for Conformity Assessment by Product Type.
• Understanding the impact the Directive will have on developing and marketing new Medical Device products.
• An overview of key areas of the Directive:
  • Scope of application and definition.
  • Essential Requirements.
  • Medical Device Type & Process Path.
  • Medical Device Technical File.
  • Clinical Investigations.
  • Clinical Evaluations.
  • Notified Bodies.