It is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition. This new regulation requires manufacturers to demonstrate appropriate levels of clinical evidence to gather the right clinical data based on the class of the IVD, intended purpose, the software involved and whether the software is independent or combined or an accessory?
What is the step-by-step process for performance evaluation and demonstration of clinical evidence? What are the key components of performance evaluation of an IVD and related SaMDs? To find answers for all your queries, you may have to understand the following :
- Overview of IVDR, with a focus on SaMD
- Classification of IVDs based on the intended purpose and risk
- Overview of performance data requirements for IVDs under the EU IVDR
- Scientific validity reports, clinical performance reports: How they are defined for a SaMD, details of the elements and how to establish them?
- Analytical performance: Key elements for a software, both as an independent and in combination, including verification and validation studies, with examples
- How the performance data requirements vary with Class of the IVD?
- Post-marketing compliance requirements
- Sufficient clinical data, based on the state of the art
To gain clear-cut insights on the performance of diagnostic devices, join Freyr’s exclusive webinar on Demonstrating Performance of Diagnostic Devices for IVDR Compliance, scheduled on June 16, 2021.
Are you aiming for a compliant EU IVDR transition? Register now!