The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostics (IVD). This regulation comes into full effect in May 2022.
Did you know
- this is the greatest change in IVD regulation in the EU in the last 20 years with the new Regulation having greater regulatory requirements on IVDs than its predecessor, the IVD Directive.
- the use of laboratory developed tests (LDT), which are commonly used within European laboratories, will be significantly impacted due the more stringent regulations put forth within the new EU legislation
- patients who rely on test results for therapy decisions will be impacted if tests used do not comply to the new legislation
At Diaceutics, we will be hosting a series of DXRX collaborations to actively support labs with the transition towards the new IVDR regulation. To begin this unique series, this first collaboration opportunity is for labs to work with us to understand what support is required to prepare for the new IVDR Regulation.
Why join the collaboration:
Work with your industry peers who are facing the same challenge and have chosen to participate in this collaboration to understand:
• What support is required to become IVDR 2017/746 ready
• How this support should be delivered to be actionable for labs
• If some labs, consider themselves IVDR 2017/746 ready
Results will be shared as an aggregated and anonymized IVDR baseline benchmark report.
To allow us to assess the potential impact of IVDR non-compliance, please select one of the 3 indications (Breast cancer, Acute Myeloid Leukemia, Ovarian Cancer) and ensure that your lab assay details reflect:
1. Current testing methods and turnaround times associated with precision medicine (PM) biomarkers for the selected indication
2. Q1, Q2 and Q3 2020 testing volumes for 3 PM biomarkers associated with the selected indication
3. Q1, Q2 and Q3 2020 indication volumes for the selected indication
*Please note, where multiple assays are available in-house, these must be logged as individual assays per technology