Digital Health April 24, 2024
The new EU AI Act will have global reach – and a big impact on the medtech and life sciences sector. By Sharon Lamb, Deniz Tschammler and Lorraine Maisnier-Boché from international law firm McDermott Will & Emery
As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology.
Software (including AI) with a medical purpose is already regulated in Europe and the United Kingdom as a medical device and requires comprehensive assessment before it can be placed on the market under EU Medical Device Regulations 2017 (MDR) and the EU In Vitro Diagnostic Medical Devices...
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