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, and DEKRA expert Liz Gommans 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)
- Notified Body process and expectations - Liz Gommans (Regulatory Affairs Specialist at DEKRA)
- Practical insights - Kristiane Schmidt (Principal Consultant)
- Practical insights - Mike Szymonik (Senior Consultant)
- Live Q&A