The European Society for Medical Oncology (ESMO) has been actively advocating for urgent reforms to the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR), which has created unintended barriers to clinical cancer research and patient access to innovative cancer diagnostics and treatments. These efforts have helped secure commitments from the European Commission (EC) and significant recognition of the issue by EU Member States and the EU Parliament (EP).
IVDR Challenges and ESMO’s Proposals
Since its implementation, the IVDR has caused delays in clinical trials due to fragmented processes, lack of harmonisation, and incomplete infrastructure. ESMO has highlighted these issues in ongoing discussions with Members of the EP, EU permanent representations and the EC, presenting specific recommendations to address the challenges:
- Harmonised processes and timelines for performance study authorisations across Member States.
- Simplified regulatory pathways for innovative technologies addressing unmet medical needs.
- Targeted legislative revisions to reduce administrative burdens and mitigate delays in patient access.
Progress at the EU Level
At the 3rd December 2024 EPSCO Health Council, several Member States emphasised the pressing need to reform the IVDR and Medical Devices Regulation (MDR). This builds on the European Parliament’s October resolution calling for, by the end of Q1 2025, delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible.
During the European Parliament’s approval hearings in November 2024, and following ESMO’s engagement with EC and MEPs, Health Commissioner Olivér Várhelyi pledged immediate measures to simplify the framework and reduce regulatory burdens, alongside a targeted evaluation to assess its effectiveness. A legislative review of the IVDR and MDR is now planned for 2025.
ESMO’s Ongoing Role
ESMO’s leadership has been instrumental in bringing attention to the IVDR’s impact on oncology research. By engaging with EU policymakers and contributing to the pivotal initiatives like the COMBINE project ESMO has ensured that the voice of the oncology community is central to the discussion.
Next Steps
The European Commission has launched a Call for Evidence, open until 21 March 2025, to gather input for its targeted evaluation. ESMO will continue to engage with policymakers and submit evidence-based insights to ensure reforms address the core issues, safeguard oncology research, and secure timely access to life-saving diagnostics and treatments for all patients with cancer.