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Are five years enough to bring together the potential of medical technology and down-to-earth legislation? With the IVDR transition period almost over, some experts fear that the answer might be no. Still, advances fuelled by AI, robotics, and machine learning are felt in many medical disciplines – it seems that humans only need to catch up. Enjoy reading! |
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Article • Regulatory issues for AI and digital pathologyIVDR: a complex issue and a 'missed opportunity'Despite a five-year transition period for In-vitro Diagnostic Medical Device Regulation (IVDR), experts fear many actors in the field are still not prepared for the regulations coming into force. |
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