Live Webinar | Time is Running Out: Submit Your IVDR Class C Application Before May 26, 2026

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:

• • 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