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Commission issues September 2021 Medical Device Newsletter

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has published the September 2021 copy of its Newsletter for Medical Devices, copy obtainable from here.

The Newsletter covers, among other topics:

  • A webinar for patients
  • Launch of a UDI Helpdesk
  • Transitional provisions for IVD certification
  • Q&A for specific combinations of medicinal products and medical devices
  • Rules for Eudamed registration
  • Identification numbers for clinical investigations
  • IVDR code explanatory notes
  • Notified body application forms
  • UDI system
  • Harmonised standards