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.
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
DR. SEBASTIAN GRÖMMINGER
Johner Institute GmbH
DDR. KARINA HELLBERT
Legal Expert on Medical Devices
Polak & Partner
DI ANDREAS OBERLEITNER
Head of Regulatory
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.