Mastering EU MDR Compliance: A Guide to Navigating Updated Standards and Ensuring Conformity Navigating the complexities of the European Union Medical Device Regulation (EU MDR) can be challenging for any medical device manufacturer. This article focuses on how changes to standards can impact a medical device’s conformity with the EU

FDA Issues Revised Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs Introduction In today’s digital age, the rapid spread of misinformation about medical devices and prescription drugs poses significant risks to public health. To address this, the FDA has released an updated draft guidance titled “Addressing Misinformation

Key Points of the FDA Guidance on Electromagnetic Compatibility (EMC) of Medical Devices The FDA’s comprehensive document, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” was published on June 6, 2022. This final guidance supersedes the 2016 version, providing updated recommendations for premarket

Understanding FDA’s Guidance on Sterility Information in 510(k) Submissions In January 2024, the FDA released an updated guidance document titled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.” This final guidance supersedes previous versions from 2016 and provides the latest recommendations for

Key Differences in Preparing a Risk Management File for EU MDR Certification Compared to an FDA 510(k) Submission Introduction: Navigating the intricacies of medical device regulation necessitates a deep understanding of the distinctions between the European Union Medical Device Regulation (EU MDR) and the U.S. FDA’s 510(k) submission process. Each

Essential Drug Delivery Outputs (EDDOs) for Devices Intended to Deliver Drugs and Biological Products The FDA has recently released a draft guidance document titled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.” This guidance is designed to provide comprehensive recommendations for medical device manufacturers on

Navigating FDA Submissions for Off-the-Shelf Software in Medical Devices Understanding Off-the-Shelf Software (OTS) OTS software refers to software developed for general-purpose computing and not specifically for a particular medical device. When incorporated into medical devices, manufacturers must ensure its safety and effectiveness, even though they don’t control the software’s development