Regulation (EU) 2017/746 establishes the rules applicable within the EU concerning the placing on the market of In-Vitro Diagnostic (IVD) medical devices, including tests that ”provide information to predict treatment response or reactions”. The purpose of this regulation, which has been in force since May 26, 2022, is to ensure high standards of quality, performance, and safety for IVD medical devices. Manufacturers must develop and validate their devices according to specific requirements, maintain stringent quality management systems, file all the information of their products in a centralized European database, undergo audits by notified bodies, keep post-market surveillance systems and many other obligations. Continuous compliance is not only legally required, but a guarantee to users and patients. Products that fulfill the requirements are distinguished with the IVD CE mark. IndiTreat® CRC Start, Extend and Explore are CE IVD-marked tests. As a healthcare professional, you can use them to assess patient-derived tumoroids’ sensitivity to drugs and use that information to individualize the treatment strategy for your patients. Legally, safely, and efficaciously. The importance of CE-IVD marking
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