The new European Union (EU) In Vitro Diagnostic Regulation (IVDR) 2017/746 warrants the attention of stakeholders of Precision Medicine. This regulation, which comes into full effect in May 2022, is the greatest change to in vitro diagnostic (IVD) regulations in the EU in the last 20 years. It imposes significantly greater regulatory requirements on IVDs than its predecessor, the IVD Directive and, ultimately, affects IVD manufacturers and those in the supply chain.
Labs, in particular, will be affected as the regulation may significantly restrict the use of laboratory developed tests (LDTs), which are also referred to as in-house developed tests. Commonly used within European laboratories, LDTs will be significantly impacted by the more stringent regulations included in the IVDR EU. Potentially, the IVDR EU could precipitate a significant lack of availability of tests that are required to guide relevant treatment decisions for patients—and, ultimately, negatively impact patient care.
Diaceutics has been working with labs to determine likely hurdles the IVDR will pose to the use of LDTs, and what labs may need to do to overcome these challenges. To help labs prepare for the IVDR EU, Diaceutics is sponsoring a marketplace collaboration via DXRX - The Diagnostic Network®, the world’s first diagnostic network for Precision Medicine. Entitled Understanding IVDR 2017/746 Regulation Readiness Within European Labs, this IVDR-specific collaboration is the first in a series of DXRX collaborations to actively support labs with the transition towards the IVDR regulation. (For more information on this collaboration, click here.)
By participating in this collaboration, labs will be able to work with industry peers who are facing the same challenges and will gain a better understanding of:
- What support is required to become IVDR 2017/746 ready,
- How this support should be delivered in order to be actionable for labs, and
- Which labs consider themselves IVDR 2017/746 ready.
This live collaboration also will generate an aggregated and anonymized IVDR baseline benchmark report to be shared among the collaborators.
A DXRX Marketplace collaboration such as this one is an opportunity for multiple stakeholders to work together to solve real-world testing challenges ensuring every patient gets the treatment they deserve. On DXRX - The Diagnostic Network®, collaborators work end-to-end on any aspect of diagnostic development and commercialization, either by joining sponsored collaborations or creating their own collaborations on the marketplace.
To further accommodate stakeholders in Precision Medicine, Diaceutics is sponsoring free, 1-hour webinars focused on the changes coming with the impending IVDR legislation. The first webinar, held in early December, provided insight from an expert panel on the potential problems posed by the IVDR for LDT use, and what steps labs will likely have to take to overcome them.
The next free IVDR-focused webinar will be held in January 2021. Details will be released soon.
DXRX - The Diagnostic Network® is an end-to-end solution for the development and commercialization of Precision Medicine diagnostics, from biomarker discovery to in-market test availability. The network enables a vibrant marketplace where all stakeholders in Precision Medicine come to find trusted partners for collaboration on Precision Medicine diagnostics in a secure, standardized way.