European Society for Radiotherapy and Oncology (ESTRO), shared on LinkedIn:
“ESTRO Signs Joint Statement on AI-Enabled Medical Technologies Regulation, Artificial Intelligence holds immense potential in radiation oncology and healthcare, supporting earlier diagnosis, more personalised treatments, enhanced clinical decision-making, and improved patient outcomes.
To fulfill this potential, the radiation oncology community requires a regulatory framework that is both safe and workable.
ESTRO has joined MedTech Europe and partner healthcare organisations in signing a joint statement regarding the ongoing revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
As AI continues to transform radiation therapy and cancer care, ESTRO supports a streamlined, single regulatory pathway that incorporates AI Act requirements directly into MDR/IVDR.
This approach avoids double regulation, ensures high safety standards, and accelerates patient access to essential AI innovation.
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