IVDR Legacy Extension Deadline – May 2025
May 26 All day
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:
Submission of an application to a Notified Body
✅ Class D devices – by 26 May 2025
✅ Class C devices – by 26 May 2026
✅ Class B & Class A sterile devices – by 26 May 2027
✅All classes of IVD legacy devices – Implementation of an IVDR-compliant Quality Management System (QMS) – by 26 May 2025
Failing 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.
Is your company on track for compliance? Let’s discuss how to navigate this critical regulatory shift.
Legacy device manufacturers: Important deadlines & steps · MDlaw – Information platform on European medical device regulations: IVDR Legacy Extension Deadline – May 2025