The European Society for Medical Oncology (ESMO) has raised concerns about the unforeseen impact of the implementation of the European Union’s (EU) Regulation on In Vitro Diagnostic Medical Devices (IVDR) on patient access to clinical trials utilising in-vitro diagnostics, with EU Commissioner for Health Stella Kyriakides, and called for concrete solutions that benefit cancer patients.
The IVDR, adopted by the EU legislators in April 2017, establishes a new regulatory framework for in vitro diagnostic medical devices, whilst aiming to ensure a high level of public health and patient safety in Europe. The Regulation covers, amongst other things, the placing on the market and making available on the market of in vitro diagnostic medical devices in the EU.
Since the entry into application of the IVDR in May 2022, various issues have occurred affecting the implementation of the new legislation. The coordinated process set out in the legislation, as well as the required infrastructure and guidance, are currently not yet fully established. This situation is resulting in fragmented initiation processes for clinical trials using in vitro diagnostics, including clinical trials conducted in the oncology space.
Having raised this issue with the European Commission, ESMO intends to work with the EU institutions and all involved stakeholders on addressing any negative impact on oncology trials, whilst aiming to ensure that cancer patients receive swift access to innovative treatments.