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UID:10000012-1748217600-1748303999@www.obelis.net
SUMMARY:IVDR Legacy Extension Deadline – May 2025
DESCRIPTION:For in vitro diagnostic (IVD) manufacturers navigating the transition to the In Vitro Diagnostic Regulation (IVDR)\, a key deadline is approaching. The IVDR legacy extension applies only if manufacturers meet specific requirements: \n\n\n\nSubmission of an application to a Notified Body \n\n\n\n✅ Class D devices (high-risk IVDs that were self-certified under IVDD but now require a Notified Body under IVDR)- by 26 September 2025 \n\n\n\n✅ Class C devices – by 26 May 2026 \n\n\n\n✅ Class B & Class A sterile devices – by 26 May 2027 \n\n\n\n✅All classes of IVD legacy devices – Implementation of an IVDR-compliant Quality Management System (QMS) – by 26 May 2025 \n\n\n\nFailing to meet these and existing legacy conditions means the extension will not apply\, and full IVDR compliance will be required. Manufacturers should act now to ensure a smooth transition and avoid market disruptions. \n\n\n\nIs your company on track for compliance? Let’s discuss how to navigate this critical regulatory shift. \n\n\n\n \n\n\n\n\n\n\n\n\nLegacy device manufacturers: Important deadlines & steps · MDlaw – Information platform on European medical device regulations: EUDAMED Deadline
URL:https://www.obelis.net/events/ivdr-legacy-extension-deadline-may-2025/
CATEGORIES:Deadlines
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