At Asphalion, we’re dedicating this week to highlighting the importance of MedTech. Our team of MedTech consultants, working in synergy with our pharmaceutical and scientific consultancy services, helps you stay ahead of market challenges while navigating regulatory and quality requirements.
Today, we’re putting the spotlight on the MDR & IVDR and the proposed changes currently on the table.
In December 2025, the European Commission published a legislative proposal to amend both the MDR and the IVDR.
In this carousel, we explore the proposal’s objectives, the key measures aimed at creating a more proportionate regulatory framework, the main proposed changes, and how the proposal seeks to better support innovation and address the needs of specific patient groups, among other topics.
Stay tuned for insights to help you navigate the evolving regulatory landscape for AI in medical devices!
Throughout the week, we’ll be sharing best practices, regulatory updates, and expert insights—including our webinar, “Clinical Data Exemptions for Software: What Evidence Does Your MDSW Really Need?”—alongside valuable resources to support your Medical Device Software (MDSW) development and compliance strategies.
Need help navigating your MedTech strategy? At Asphalion, we are committed to guiding you through each step of the regulatory pathway. Get in touch with us!: [email protected]
Check out our carousel here: Carrusel MDR & IVDR – MedTech Week
Register to our webinar “Clinical Data Exemptions for Software: What Evidence Does Your MDSW Really Need?“: https://bit.ly/4xRtjsf
