Medical Devices Newsletter - Issue 44 - Jan 2016

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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

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