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Yesterday, the EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of safe devices that are essential for healthcare systems. The amending regulation extends...
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In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
5 min read
Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...
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The landscape of modern healthcare has been completely transformed by the development of cutting-edge medical devices. From life-saving implants to...
