Device Advice by RQM+

The Proposed Amendments to MDR and IVDR | MedTech Voices

Listen Later

Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal.

All current transition timelines have been extended by 2.5 years with new deadlines ranging from 31 December 2027 for highest risk devices to 31 December 2029 for the lower risk devices.

There are some conditions around these transition deadlines, including:

  • No significant changes can be made to the device
  • PMS and vigilance requirements under IVDR must be met
  • An IVDR compliant QMS must be implemented by 26 May 2025
  • An application must be lodged with the notified body at least two years ahead of the transition deadlines

    • -

    📹 ⁠⁠⁠⁠⁠⁠⁠View and share this clip on LinkedIn.⁠⁠⁠⁠⁠⁠⁠

    📲 ⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠⁠⁠⁠

    📚 ⁠⁠⁠⁠⁠⁠⁠See on-demand content in our Knowledge Center.⁠⁠⁠⁠⁠⁠⁠

    📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

    ...more
    View all episodesView all episodes
    Download on the App Store
    Device Advice by RQM+By RQM+
    • 4.8
    • 4.8
    • 4.8
    • 4.8
    • 4.8

    4.8

    34 ratings

    More shows like Device Advice by RQM+

    View all
    Global Medical Device Podcast powered by Greenlight Guru by Greenlight Guru + Medical Device Entrepreneurs

    Global Medical Device Podcast powered by Greenlight Guru

    93 Listeners

    Medical Device made Easy Podcast by easymedicaldevice

    Medical Device made Easy Podcast

    20 Listeners