Stay informed with the latest updates in Medical Technology, Regulatory Affairs, International Standards, and Global Safety Recalls.
Feature Update
FDA Issues New Guidance on AI-Enabled Medical Devices
The FDA has released draft guidance on AI- and machine learning-enabled device software, outlining lifecycle management expectations and marketing submission recommendations. The guidance builds on the agency’s Predetermined Change Control Plan (PCCP) framework, giving manufacturers a clearer path to pre-authorize future AI updates while strengthening transparency and postmarket performance monitoring.
Latest Industry Updates
curated news from leading medical technology organizations and regulatory bodies.
The European Commission has published a new set of harmonised standards supporting compliance with the EU Medical Devices Regulation (MDR). The update includes revised EN ISO and IEC standards to help manufacturers demonstrate conformity with regulatory requirements.
Source: European Commission
The U.S. FDA has released eSTAR Version 7.0, introducing updated submission templates aligned with the latest Human Factors guidance. Medical device manufacturers are encouraged to transition to the new version before older templates are retired.
Source: FDA
Fresenius Kabi issued a software correction for Ivenix Large Volume Pumps after identifying software anomalies that could interrupt infusion therapy and potentially result in serious patient harm. FDA classified the action as a medical device correction.
Source: FDA – U.S. Food and Drug Administration
FDA Updates AI-Enabled Medical Device List
The U.S. FDA has updated its official AI-Enabled Medical Device List, providing transparency on authorized artificial intelligence technologies used in medical devices and supporting innovation in digital healthcare.
Source: FDA – U.S. Food and Drug Administration
ISO has officially published ISO 20417:2026, replacing the 2021 edition. The revised standard updates requirements for medical device labelling, packaging information, identification, and instructions for use to support global regulatory compliance.
Source: International Organization for Standardization (ISO)
The European Commission confirmed that the first four EUDAMED modules—including Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance—will become mandatory from 28 May 2026, marking a major milestone in EU MDR/IVDR implementation.
Source: European Commission
North American Rescue issued a correction for selected first aid kits containing TRUE METRIX Blood Glucose Monitoring Systems after Trividia’s Class I recall. Users are advised to follow updated instructions and inspect affected kits before continued use.
Source: FDA – U.S. Food and Drug Administration
Samsung announced that the upcoming Galaxy Ring will become the first smart ring featuring FDA-cleared sleep apnea detection, marking a significant milestone in wearable medical technology.
Source: Tom’s Guide