IVDR Legacy Roadmap for Class C Devices

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Frequently Asked Questions

Does the 26 May 2026 deadline apply to all legacy IVDs? 

No, this deadline specifically applies to legacy devices that did not require CE certificate under IVDD and that will become IVDR class C device. 

What happens if I don't apply to a Notified Body by 26 May 2026?

Your device may no longer be legally placed on the EU market. Formal application to Notified Body before 26 May 2026 is legal condition to enjoy the extended transition period and continue placing the device on the market. 

When must my IVDs, upclassified to IVDR class C, be fully IVDR compliant?

By 31 December 2028, IVDs upclassified to IVDR class C must complete the transition and fully met IVDR requirements, ensuring they can continue to be lawfully placed and made available on the EU market. 

Can I continue placing my IVDs, upclassified to IVDR class C, on the market after 26 May 2026?

Yes, if you meet all transitional conditions and have submitted your application to a Notified Body before the deadline. Your device must continue to comply with IVDD requirements and show ongoing progress towards full IVDR conformity. 

Can Obelis Group support my legacy device transition?

Obelis provides IVDR transition support tailored to IVDs upclassified to IVDR class C. Our team assists manufacturer with every stage of the process, from upgrading and aligning QMS with IVDR requirements to preparing and submitting a complete application package to the Notified Body. As your Authorised Representative, we guide you throughout the entire transition period. 

Learn More About IVDR & Transition Steps 

Watch our expert webinar to understand what the 26 May 2026 IVDR deadline means for your device and market access. 

Obelis supports IVDs manufacturers by: 

Preparing your IVDR Notified Body Application

Reviewing documentation and performing gap assessments

Ensuring correct transitional PMS, vigilance & labelling compliance

Acting as your Authorised Representative throughout the transition