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Introduction This document provides a first set of answers, that will be continuously developed and updated, to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4 for manufacturers. This Frequently Asked Questions (FAQ) document is primarily aimed at (but not limited to) medical device manufacturers, notified bodies and competent authorities. All..

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..

This is the second in our series of regulatory updates on the EU AI Act. We discussed AIA in our first regulatory update, the EU Artificial Intelligence Act. The EU AIA introduces a comprehensive framework for AI-enabled device regulation in the EU. In this regulatory update we discuss key elements of the regulation and best practices, enforcement and oversight, AI regulatory sandboxes and real-..