Date: Tuesday, April, 28, 2026
Time: 16:00 - 17:00 CET | 10:00 - 11:00 am EDT
Location: Virtual
Introduction
The transition to IVDR is entering its final phase, and the clock is ticking for Class C IVD manufacturers. Under the IVDR, Class C devices now require assessment by a notified body. It is a major shift from the IVDD where no such review was required. To ensure market continuity, you must submit your application to a notified body before May 26, 2026 and have a signed contract in place by September 2026.
In this session, Qserve experts Kristiane Schmidt and Mike Szymonik educate you about the importance of being on time and how to ensure a smooth IVDR transition for your devices.
The webinar consists of a 45-minute presentation, and a 15-minute live Q&A session. Questions for the Q&A can be submitted through the registration form, by email at marketing@qservegroup.com, or during the webinar.
Learning Objectives:
We’ll share practical insights on:
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- What to do as a manufacturer to comply — first time right
- Steps for the contract with Notified Body's.
- How to prepare: a practical action plan
- Steps for setting up the agreement with a Notified Body
- How to ensure a complete, high quality application — first time right
- Why you must prepare your Technical Documentation now.
- How to use your time effectively during the conformity assessment
Who should attend?
This webinar is designed for anyone involved in building, scaling, or supporting IVD, including:
- Regulatory affairs experts
- Clinical affairs experts
- Project managers
Agenda
- Welcome & introduction - Inette Nieveen (Head of Medical Devices)
- Practical insights - Kristiane Schmidt (Principal Consultant)
- Practical insights - Mike Szymonik (Senior Consultant)
- Live Q&A