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SUMMARY:Winning with IVDR: Compliance Strategy\, Class C Pathways & NB Engagement
DESCRIPTION:The IVDR transition is reshaping how IVD manufacturers approach compliance\, evidence\, and certification. This session will guide you through the most critical elements of the journey\, from transition timelines and legacy provisions\, to EUDAMED and UDI requirements\, and what they mean in practice. \n\n\n\nWe will also dive into Class C classification and conformity assessment pathways\, highlight the most common clinical evidence gaps identified by Notified Bodies\, and share practical insights on how to work more effectively with Notified Bodies\, including smarter communication and selection strategies to support successful approvals.Join us to gain clarity\, reduce compliance risks\, and strengthen your IVDR strategy. Register now to secure your spot.
URL:https://www.obelis.net/events/winning-with-ivdr-compliance-strategy-class-c-pathways-nb-engagement/
CATEGORIES:Webinars
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DTSTART;TZID=Europe/Brussels:20260528T150000
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SUMMARY:EUDAMED Readiness for MDR & IVDR: Registration Obligations and Timelines
DESCRIPTION:With EUDAMED obligations becoming enforceable from 28 May 2026\, manufacturers and economic operators should already be preparing for upcoming registration and compliance requirements under MDR & IVDR. \n\n\n\nDuring this expert-led session\, our speakers will provide practical insights into the EUDAMED regulatory framework\, key timelines and deadlines\, affected economic operators\, MDR & IVDR registration requirements including legacy devices\, as well as the role of the Authorised Representative in EUDAMED verification processes. \n\n\n\nJoin us to gain a clearer understanding of the upcoming EUDAMED deadline and its impact on medical device and IVD manufacturers operating in the EU.
URL:https://www.obelis.net/events/eudamed-webinar-2026-mdr-ivdr-registration-deadlines/
CATEGORIES:Webinars
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