MD3: Navigating the regulatory maze: challenges of medical device software


Less than a week after the release of the guidance MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations for MDSW intended to work in combination with hardware or hardware components, Mariana Madureira presented competent authority’s opinion on putting MDSW on the market. The guidance is part of the European Commission’s efforts to further clarify requirements for MDSW under the Medical Device Regulation (EU) 2017/745 which came into effect in May 2021 with recent extensions applicable to legacy devices.

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