IVDR: A complex issue and a ‘missed opportunity’
In his lecture at the 8th Digital Pathology & AI Congress in London, BBMRI.at Director Professor Kurt Zatloukal (Med Uni Graz) raised concerns that many organizations in the field of digital pathology and AI might not yet be prepared for the European In-vitro Diagnostic Medical Device Regulation (IVDR).
The IVDR is in place since 2017 with a transition phase until May 2022 and requires new and about 80% of all diagnostics that are already on the market in Europe to provide additional data in order to comply with this new law. Also software – including AI-based analysis technology – is in its scope. The IVDR demands increased documentation on scientific evidence, analytical and clinical performance, including pre-analytical information about biological specimens (to be) used/analysed with the IVDs (e.g. software). Standards such as the ISO 20166-4 on pre-analytical requirements for tissue, which is typically used for digital pathology and computer-based analysis of tissue slides, are relevant and helpful in this context.
