In this issue 

HPRA Updates

• Brexit Preparations
• COVID-19 Updates
  • IVD Testing
  • Notified Bodies and the Response to COVID-19
  • Remote Inspections - HPRA Process Changes
  • Temperature Measurement Systems

EU Co-operation

• Medical Devices Regulation (MDR): Date of Application May 2021
  • CIE Working Group Update
• MDCG Guidance for Drug-Device Combinations
• EU Vigilance Guidance and Q&A
  • Manufacturer Incident Report (MIR) Q&A
  • PSUR (Periodic Safety Updates Report) Guidance
  • Additional Vigilance Updates

Published: 30 July 2020