ESMO has highlighted the unintended consequences of the In Vitro Diagnostic Regulation (IVDR), that risk Europe losing its position as a global leader in cancer research. While the IVDR was designed to strengthen patient safety and enhance the regulatory framework for in vitro diagnostics, its fragmented and inconsistent implementation is causing severe disruption to clinical research. The delays and administrative burdens it has created risk driving trials - and investment - away from Europe.
ESMO’s submission to the European Commission’s targeted evaluation highlights that these barriers are not theoretical; they are already having a tangible impact. The lack of harmonisation and clear guidance has led to prolonged approval times, inconsistent regulatory interpretations across Member States, and significant uncertainty for sponsors.
Without urgent intervention, Europe risks losing its competitive edge, limiting patient access to innovative treatments, and weakening its position in global oncology research.
Although initiatives such as the European Commission’s COMBINE project aim to alleviate some of these challenges, they are voluntary in nature and unlikely to provide the comprehensive solutions needed. ESMO is calling for structural regulatory reform to ensure that IVDR implementation supports, rather than obstructs, high-quality cancer research.
In order to tackle these challenges,, ESMO has proposed that the following measures be considered for inclusion within any future revision of the IVDR:
- A harmonised, single-entry system for IVDR applications.
- Standardised protocols and guidance to ensure regulatory consistency.
- Capacity-building programmes and training for regulatory authorities.
- A reference assay model with ring validation for biomarkers.
- A rapid-feedback mechanism within EUDAMED.
- Standardised timelines and documentation requirements.
- A time-limited regulatory ‘sandbox’ for academic trials and those in areas of high unmet medical need.
ESMO stands ready to work with the European Commission and other policymakers to ensure that regulatory frameworks uphold patient safety while also enabling timely, high-quality research.
Read ESMO’s full submission to the European Commission here.
For further information, please, contact: publicpolicy@esmo.org