Let’s Talk AI in the context of Medical Devices & IVDs!

There’s a wave of change coming to the world of medical devices and IVDs — and AI is at the heart of it. 

Join us for an informal afterwork session and let's discuss the latest updates that will shape the future of our work:

🧠 EU AI Act – What It Means for Us As of 2 August 2027, the high-risk classification under Article 6(1) of the AI Act will apply to medical devices and IVDs undergoing conformity assessment under MDR and IVDR. Are we prepared for what that means in practice?

📄 MDCG 2025-6 (June 2025) The newly published MDCG guidance on the interplay between the MDR, IVDR, and the AI Act gives long-awaited clarification on regulatory overlap and expectations — But how much clarity does it really bring?

📘 IEC 62304 – 2nd Edition on the Horizon The upcoming revision of this key software lifecycle standard will include requirements for AI-enabled medical devices, adding new layers to software compliance.

📱 MDCG 2025-4 (June 2025) Not directly AI-related, but still highly relevant: this new guidance addresses the safe making available of Medical Device Software (MDSW) apps on online platforms.

It will be very interesting to see what practical consequences this brings for software distribution and oversight.

This is a great opportunity to get up to speed, ask questions, and share insights in a relaxed setting.

📍 Location: Frösundaviks Allé 1, Stockholm
🕓 Date & Time: 2025-09-16, 16:00 – 18:00 16.00

Networking 16.30
Presentation by Vanessa Caldeira 17.00
Group Discussions: Key challenges, strategies & solutions 17.30
Summary of the discussions and key take aways.

🍕 Snacks & drinks provided

Register to the event

Let’s connect, learn, and explore how these changes will impact our projects and responsibilities. Looking forward to seeing you there!