HPRA Medical Devices Newsletter – Issue 54 – November 2021

Download: hpra-medical-devices-newsletter-issue-54-november-2021.pdf 988 KB

Published 30 November 2021

In this issue

  • IVDR Transition and Implementation

  • COVID-19 and Antigen Tests

  • HPRA Updates

    • Review of Medical Device Compliance/Inspection Activities

    • Eudamed Update

    • Certificates of Free Sale

    • Clinical Investigation – Process and Guidance Updates

    • HPRA Website Survey

  • Stakeholder Engagement

    • HSE Webinar

    • IPPOSI Workshop

  • EU Cooperation and Guidance

    • MDCG Classification Guidance

    • MDCG Update



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