12 September
11:00 AM - 12:00 PM ET | 5:00 PM - 6:00 PM CET
Sponsored By:
Live! #82 - MDR and IVDR Amendments: Strategies for Supply Interruption Compliance
Virtual Event
Speakers:
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)
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.
Register Now