Quality Management System Requirements under IVDR 2017/746

ABOUT THE WEBINAR

The in vitro diagnostics regulation 2017/746 (IVDR) imposes general requirements for the manufacturer’s quality management system (QMS) to ensure compliance with the IVDR. These requirements must be met by manufacturers wishing to place their devices on the market for the first time. Further, Regulation 2024/1860 introduced a sliding timeline for full IVDR compliance of legacy devices based on device classification. Under this regulation, manufacturers of all legacy devices must put in place a QMS that complies with IVDR requirements no later than May 26, 2025.

In this webinar, hosted by TÜV SÜD, our professionals will discuss the requirements for an IVDR-compliant QMS and associated timelines, as well as the Notified Body’s approach to assessing compliance.

We'll discuss:

• Timelines for QMS implementation for legacy devices
• General requirements for an IVDR-compliant QMS
• Notified body approaches to QMS audits for IVDR compliance
• Lessons learned

Join us to gain insights into understanding the requirements for an IVDR quality management system and lessons learned.

Date: 07 May 2025, Wednesday
Time:

Duration: 60 mins (45 mins panel discussion + 15 mins Q&A)

The recording of the webinar will be made available on TÜV SÜD’s website in a week's time to registered participants.

WEBINAR OUTLINE

Topic 1: Timelines for compliance of legacy devices

Topic 2: General requirements for a compliant QMS

Topic 3: Notified body approach to assessing QMS conformity

Topic 4: Lessons learned

Conclusion & Q&A

SPEAKERS & MODERATOR