IVDR WEBINAR SERIES

Join our Webinars!
Together with our regulatory and clinical partners, we are supporting laboratories in tackling the most important changes with the IVDR. Contact us via info@platomics.com if you have questions or issues you want to have addressed.

Part 1 of our one-hour Webinar Series was:

A practical guide to Lab Developed Tests for genetic testing

May 26th marked the last year of the 5-year transition period to fully implement the EU-IVDR on May 26th 2022. Hence, Platomics invited interested stakeholders to the 1st part of our Webinar series on the IVDR on June 23rd, 11:00 to 12:00h CEST.

SCOPE:

In this webinar, we outlined and clarified the most important requirements to establish an LDT for genetic testing and gave practical advice how to achieve regulatory conformity. Additionally, we included a legal expert, specialized on the IVDR, to discuss and assess possible risks and consequences.

Part 1: How the IVDR regulates Lab Developed Tests

Dr. Sebastian Grömminger, Johner Institute

Part 2: Legal interpretation with focus on Article 5 of the IVDR

DDr. Karina Hellbert, Polak & Partner

Part 3: Documentation and processes to set up a Lab Developed Test

DI Andreas Oberleitner, Platomics GmbH

YT_20210623_Webinar_PlayButton.jpg

THE SPEAKERS

Sebastian Grömminger.JPG

DR. SEBASTIAN GRÖMMINGER

IVDR consultant
Johner Institute GmbH

Karina Hellbert.JPG

DDR. KARINA HELLBERT

Legal Expert on Medical Devices
Polak & Partner

Andreas Oberleitner.JPG

DI ANDREAS OBERLEITNER

Head of Regulatory
Platomics GmbH

Background:

While the new regulation sets a whole new framework and causes far-reaching changes for genetic testing, little has been discussed about the practical implications for the manufacturers of diagnostic devices and about the effect on the lab itself.

To understand these changes on Lab Developed Tests, we not only need to clarify what the IVDR demands but also where the regulations are rooted in to interpret them correctly. We outlined and clarified the most important legal requirements to establish an LDT and give practical advice how to achieve regulatory conformity. Additionally, we included a legal expert, specialized on the IVDR, to discuss and assess possible risks and consequences.

What happens to Lab Developed Tests?

CE certification of genetic tests for medical purposes will replace most Lab Developed Tests (LDTs) after the EU-IVDR enters into force. However, LDTs will still be necessary 1) in the short to mid run until sufficient Notified Bodies and CE-IVD-Devices are commercially available and 2) for specific medical questions. These LDTs will be exempt in Article 5 (5) of the IVDR from many of the requirements for an CE-IVD-Device, but comparable requirements are placed on LDTs here instead.


To whom this webinar was addressed:

This Webinar was mainly addressed to medical labs, lab associations, and hospitals who need to establish LDTs in a regulatory compliant way to further provide such genetic testing services.

PRESENTED BY