IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs

Description: The new IVDR has a huge impact on the IVD manufacturers but even a bigger impact on IVD users and health institution laboratories using own In House developed tests for diagnostic purposes in Europe. This new regulation has a strict deadline of 26 May 2022, which is only two years away. Will there still be tests available on the EU market? And how are the in-house developed test complying to the Article 5.5 requirements of the IVDR.
During this session the portfolio analysis and regularly strategy opportunities are discussed and examples given for both the health institution labs with the in-house developed test as well as for the IVD manufacturer with current In vitro diagnostic tests on the market.
These two groups developing diagnostic tests, both manufacturers vs laboratories, are often seen as "competitors" . However both organization may benefit from each other when there is a close collaborations in the early regulatory strategy process and portfolio analysis.
During this session the benefit and risk for the current IVD manufacturer to transfer their current most self-declared IVDs from IVDD to IVDR compliance, and under notified body control, will be explained. And for the in house developed tests designed at testing laboratories the potential opportunities to comply to the Article 5.5 of the IVDR is discussed. The portfolio analysis both at labs and manufacturers and the accompanied regulatory strategy plan for the product portfolio's may lead to optimizing the diagnostics tests available and to be used at the hospital laboratories and therefore leading to optimized patient diagnosis.
Overall the need for a close collaboration between the IVD manufacturers and Testing Laboratories is KEY to guarantee that after 26 may 2022 IVD tests are available and patients are getting the proper and optimized diagnostic tests and can be treated accordingly.

Presentation 1:
Consequences of the IVDR for diagnostic laboratories & consortia for innovation of laboratory diagnostics
Prof. Jacques J.M van Dongen, MD, PhD