IVDR - The most important changes affecting your software applications

The European Union In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) also regulates in-house IVDs that are manufactured by health institutions. Therefore, the IVDR also affects e.g. tumor profiling workflows of pathology laboratories, including the software applications used within tumor profiling. We have summarized the most important advantages for the use of IVDR certified CE-IVD software within in-house IVDs.

The advantages of using IVDR-certified software in tumor profiling workflows

The IVDR requires that in-house IVDs must also comply with the general safety and performance requirements of Annex I from May 2022, including performance evaluation in accordance with article 56 of the regulation. Thus, the IVDR has various implications for laboratories that employ either in-house developed software or software that was CE-marked under the repealed IVDD directive (98/79/EC). The primary benefits of using IVDR-certified software relate to product performance, product maintenance, product availability, and product innovations.

• Product performance: Since the bioinformatics pipelines and tertiary analysis are the main determinants of the overall safety and performance as well as the analytical and clinical performance of in-house IVDs for tumor profiling, the performance evaluation of in-house developed or IVDD software may not meet the requirements of the IVDR, leaving it up to the laboratory to establish IVDR compliance for this part of the workflow. When using IVDR-certified CE IVD products, compliance for this part of the workflow is ensured by the IVD manufacturer.
• Product maintenance: Tumor profiling, including the tertiary analysis, is continuously developing and therefore requires updates of algorithms and data to maintain the state-of-the-art and the clinical benefit of the in-house IVD. Employing an IVDR-certified CE-IVD ensures that the analysis remains state-of the-art and relieves the laboratory from effort intensive software and data maintenance.
• Product availability: The IVDR stipulates that in-house IVDs may no longer be marketed after May 2028, if an equivalent IVDR-certified CE-IVD is available that can fulfill the needs of the target patient group or the required level of performance.
• Product innovations: IVD products that are CE-marked under the repealed IVDD and still marketed are not allowed to be significantly further developed, which hampers the implementation of product innovations – also those that may be necessary to keep up with the state-of-the-art. IVDR-certified CE-IVDs do not have this limitation and are thus open for product innovation to maintain and even further develop the state-of the art in the field.