EPF Congress 2025: Empowering the Patient
For two days, the EPF Congress united Europe’s leading voices from across the healthcare ecosystem to engage in essential conversations about the future of patient involvement.
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European Parliament advances MDR/IVDR revision: critical implications for In Silico & Digital Health Technologies
As the European Union moves forward with revising Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), the European Parliament’s Committee on Environment, Public Health and Food Safety (SANT) is taking a central role in recalibrating the MedTech regulatory landscape.
EMA launches Pre-Submission Interactions pilot to improve MAA readiness
The European Medicines Agency (EMA) has initiated a voluntary pilot testing a revised model for Pre-Submission Interactions (PSI) ahead of initial Marketing Authorisation Applications (MAAs).
