
The Significance of the EU AI Act for Medical Devices
The EU AI Act applies a comprehensive risk-based approach to regulating digital medical products. By aligning and interacting with existing regulations like the EU MDR/IVDR and GDPR, the Act impacts AI across healthcare, focusing on patient safety, AI system efficacy, data governance, and ethical use.

MDRChats-Available on spotify
MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://chatmdr.eu/).
Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field.
Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.

MDR – language requirements for manufacturers (January 2024).xlsx
Excel document containing the language requirements for manufacturers under the Medical Device Regulation (MDR)-January 2024.
