In this issue 

• New Chief Executive appointment
• Clinical investigations of medical devices
  • Clinical Investigations and the Role of the HPRA
  • EN ISO 14155 Clinical investigation of medical devices for human subjects – Good Clinical Practice
  •  Recent updates to Clinical Investigation Guidance in Europe
• Mobile Apps – are they medical devices?
• National Medical Device eAlert System
• Automated External Defibrillators – managing your device – important information
• Regulatory updates and developments
  • Proposals for a new regulation on medical devices and in vitro diagnostic medical devices
  • CAMD
  • EU Working Groups update
  • Pilot inspection programme for Distributors of Medical Devices
• Stakeholder survey - Feedback