Webinar | IVDD to IVDR: Mind the Gap Before You Apply

Join DNV and MedEnvoy for a one-hour webinar on the IVDD to IVDR transition for Class B and Class A sterile IVD manufacturers.

Wednesday, 9 December 2026 | 10:00–11:00 EST / 16:00–17:00 CET | Online

With key IVDR transition milestones approaching, Class B and Class A sterile IVD manufacturers need a clear strategy for achieving compliance and successfully engaging a notified body. In this one-hour session, DNV and MedEnvoy will help manufacturers assess their readiness, identify compliance gaps, and plan for the 2027 transition milestones.

DNV will provide an overview of IVDR requirements, classification considerations, and the notified body application and conformity assessment process. MedEnvoy will explore common gaps encountered when transitioning from self-certified devices under the IVDD, the practical challenges manufacturers face in meeting IVDR requirements, and the QMS and technical documentation activities that should be prioritized.

Why the 2027 Milestones Matter

Under Regulation (EU) 2024/1860, Class B and Class A sterile IVDs that were self-certified under the IVDD can continue to be placed on the market until 31 December 2029, but only if the manufacturer meets the transition conditions. Two of those conditions fall in 2027:

• 26 May 2027: lodge a formal application for IVDR conformity assessment with a notified body.
• 26 September 2027: sign a written agreement with the notified body.

The conditions also require an IVDR-compliant quality management system, which has applied since 26 May 2025. (HPRA: IVDR transitional provisions)

What You’ll Learn

• IVDR requirements and classification: An overview from DNV of IVDR requirements and the classification considerations that affect Class B and Class A sterile IVDs.
• The notified body process: How the notified body application and conformity assessment process works.
• Common transition gaps: The gaps MedEnvoy encounters when manufacturers move self-certified IVDD devices to the IVDR, and the practical challenges in meeting IVDR requirements.
• What to prioritize now: The QMS and technical documentation activities to prioritize ahead of the 2027 milestones.

Who Should Attend

Regulatory affairs, quality, and leadership teams at manufacturers of Class B and Class A sterile IVDs that were self-certified under the IVDD and are planning their IVDR transition.

Speakers

Daryl Wisdahl

Director Consulting Services, MedEnvoy

Daryl has more than 25 years of experience in the medical device industry and has specialized in quality management system (QMS) implementation and compliance, and regulatory submissions for medical devices. He has reviewed Health Canada submissions, FDA submissions, and technical files for medical device manufacturers around the world.

Kenneth Fuh, PhD

IVDR Technical Manager, DNV

Kenneth Fuh is a biomedical engineer and diagnostics expert serving as technical lead for IVDs at DNV, where he advances global conformity assessment and regulatory excellence in medical technologies. He earned his doctorate in biomedical engineering from the University of Calgary. Earlier in his career, he co-founded Syantra Inc. and helped develop Syantra DX, a blood-based gene-expression test for early breast-cancer detection. With a background in biomarker research and diagnostic development, Fuh now focuses on ensuring the quality, safety, and performance of innovative IVD solutions worldwide at DNV.

Register

Wednesday, 9 December 2026 | 10:00–11:00 EST / 16:00–17:00 CET. A recording will be available after the session.

Learn more about DNV and MedEnvoy. If you are planning your IVDR transition now, MedEnvoy supports manufacturers with EU MDR/IVDR technical documentation, ISO 13485 quality management systems, and EU Authorized Representative services. Talk to our team.