IVDR Class C Ask Me Anything Session: Ask Your Questions Before the 26 May Deadline

A live interactive session to address your questions on Class C IVDR transition and Notified Body application ahead of the 26 May 2026 milestone

As the 26 May 2026 IVDR milestone approaches, manufacturers of Class C in vitro diagnostic (IVD) devices are entering a critical phase of transition.

For devices that were previously self-declared under the IVDD, submitting a complete application to a Notified Body is a key step to maintain access to the EU market under the extended transition timelines. At this stage, clarity, timing, and preparedness can make a significant difference.

To support manufacturers at this final and decisive stage, DNV is hosting an interactive “Ask Me Anything” (AMA) session, an open forum where you can raise your specific questions, discuss common challenges, and gain practical insights directly from our IVDR experts.

What to expect

• Open Q&A with experienced IVDR specialists
• Practical guidance on Notified Body applications for Class C IVDs
• Discussion of common gaps, expectations, and next steps
• Opportunity to exchange perspectives with industry peers

Whether you are still preparing your application or approaching submission, this session will help you clarify priorities and move forward with confidence.

Session details

• Format: Online
• Date: 12 May 2026
• Time options: 
  • 10:00 - 11:00(CET) | 05:00 - 06:00(EDT)
  • 18:00 - 19:00(CET) | 13:00 - 14:00(EDT)
• Speakers:
  • Molly Rogers, Head of IVDR Medical Europe, DNV
  • Kenneth Fuh, IVDR Technical Manager, DNV

Who should attend

This session is relevant for:

• IVD manufacturers with Class C devices transitioning from IVDD to IVDR
• Regulatory affairs and quality professionals
• Project managers leading IVDR transition activities
• Decision-makers responsible for EU market strategy