{"id":170467,"date":"2025-01-29T15:47:24","date_gmt":"2025-01-29T14:47:24","guid":{"rendered":"https:\/\/eurecat.org\/?post_type=avada_portfolio&p=170467"},"modified":"2025-01-29T15:49:24","modified_gmt":"2025-01-29T14:49:24","slug":"eu4medtech","status":"publish","type":"avada_portfolio","link":"https:\/\/eurecat.org\/en\/portfolio-items\/eu4medtech\/","title":{"rendered":"EU4MEDTECH"},"content":{"rendered":"

\"EU4MEDTECH<\/p>\n<\/div>

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Transforming the evaluation of high-risk medical devices and diagnostics in Europe.<\/strong><\/p>\n

EU4MEDTECH<\/strong> revolutionises the generation and evaluation of clinical and performance evidence<\/strong> for high-risk, innovative medical devices (MDs) and in vitro diagnostic devices (IVDs) by co-creating and validating the versatile and lifecycle-oriented EU4MEDTECH framework<\/strong>.<\/p>\n

This framework addresses the challenges posed by the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which, while ensuring higher patient safety, have increased regulatory burdens for stakeholders across the HealthTech value chain.<\/p>\n

The EU4MEDTECH framework will be operationalised through an interactive, cloud-based digital platform <\/strong>and validated across three use cases<\/strong>: class III and implantable medical devices, class C\/D in vitro diagnostic devices, and software-based medical and diagnostic devices, with clinical studies conducted for highly innovative solutions.<\/p>\n

Key MedTech stakeholders are actively engaged in co-design processes to ensure the project outcomes are applicable, scalable, and sustainable. Furthermore, the project will develop a comprehensive exploitation roadmap for widespread adoption and long-term impact.<\/p>\n

Eurecat participates in EU4MEDTECH through its IT&OT Security<\/a> Unit, by defining a knowledge graph to help the development of safe medical devices. Moreover, it develops the necessary tools to exploit this knowledge, not only in the design, but also during the life cycle of connected medical devices.<\/p>\n

The EU4MEDTECH consortium brings together expertise in MD\/IVD regulations, clinical sciences, computer science, cybersecurity, health economics, and business acceleration.<\/p>\n<\/div>

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General details<\/h3><\/span>
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Project<\/strong><\/p>\n

EU4MEDTECH \u2013 European Framework for Advanced Medical Technology Evaluation and Follow-up<\/p>\n

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Project reference<\/strong><\/p>\n

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101191683<\/p>\n<\/div>\n<\/div>

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Programme and call for tender<\/strong><\/p>\n

Project funded by the European Union\u2019s Horizon Europe programme under the call HORIZON-HORIZON-HLTH-2024-IND-06-08: Developing EU methodological frameworks for\u00a0 clinical\/performance evaluation and post-market clinical\/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs)<\/em><\/p>\n

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More information about the project<\/strong><\/p>\n

EU4MEDTECH<\/a><\/p>\n

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Related ODS<\/strong><\/p>\n

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<\/i><\/i><\/span>3. Clean water and sanitation<\/span><\/a><\/h4><\/div>
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Ensuring the security of connected medical devices, as well as maintaining the privacy of patients and healthcare personnel.<\/p>\n

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<\/i><\/i><\/span>9. Industry, innovation and infrastructure<\/span><\/a><\/h4><\/div>
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Improving and ensuring the security of connected medical devices.<\/p>\n

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