Live! #82 – MDR and IVDR Amendments: Strategies for Supply Interruption Compliance

Device Advice by RQM+

This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by ⁠⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions!

We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠at RQMplus.com.

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The recently published Regulation (EU) 2024/1860 amends the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) by introducing some significant changes that will impact manufacturers and the entire MedTech industry.

One of the changes is the introduction of a requirement for manufacturers to inform national competent authorities in cases of supply chain interruptions, or the withdrawal from the market, of certain critical medical devices and IVDs.

Join our expert panel to explore the implications of these new obligations for manufacturers and learn actionable strategies to ensure compliance.

In this comprehensive discussion, our regulatory and quality experts will cover:

• Impact Assessment: An overview of the amendments, including changes to transition timelines for IVDR and the phased rollout of EUDAMED.
• Supply Chain Management: Insights into the new obligation for manufacturers to provide advanced notice of supply chain interruptions and strategies to ensure a robust and resilient supply chain.
• Industry Perspectives: An examination of feedback from industry stakeholders and how companies are preparing for these regulatory changes.
• Compliance Strategies: Guidance on meeting the new requirements, including implementation within your Quality Management System (QMS).
• Quality and Regulatory Support: How RQM+ can support your company with regulatory change assessments, EUDAMED data management, and the implementation of new supply chain notification processes.

By attending this event, you will gain a clear understanding of the amendments to MDR and IVDR and learn practical steps and strategies to achieve compliance. Register now to stay ahead of these critical regulatory changes and ensure the continued success of your products in the European market.

Panelists and moderator:

• Erik Vollebregt – Advocaat, Axon Science Based Lawyers
• Heike Moehlig-Zuttermeister – Global Director In-Vitro Diagnostics, TÜV SÜD
• Donielle Johnson – Global Regulatory Affairs Executive
• Ed Ball – Manager, Intelligence & Strategic Execution, RQM+
• Amie Smirthwaite, Ph.D. – Senior Vice President, Scientific Affairs, RQM+ (moderator)

Certificate of Participation available upon request for live attendees.

Who Should Attend: This panel discussion is ideal for regulatory affairs professionals, operations management, quality assurance professionals, production planning and supply chain managers, and MedTech manufacturers navigating the amended IVDR and MDR requirements.

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