Europe still sees a quarter of the world's cancer cases each year, making cancer the second leading cause of death and illness in the region after cardiovascular diseases. Unless we take decisive action, lives lost to cancer in the EU are set to increase by more than 24% by 2035, making it the leading cause of death in the EU. Cross-border collaboration can address this challenge by combining data from various modalities and sources, extracting meaningful insights to deepen our understanding of cancer. However, ethical, legal, and national regulations, along with data access processes, including differing interpretations of the EU GDPR create significant hurdles. Technical interoperability issues across European cancer RIs, and patients' and citizens' rights to control who uses their personal information and for what purposes further complicate data sharing. The project will provide European researchers, SMEs, and innovators with a decentralized collaborative network, “UNCAN-CONNECT,” for cancer research. It consists of both technical components, a governance, compliance, and operational framework based on the UNCAN blueprint, with the goal of operationalizing it. The objective is to facilitate access to cancer data, promote open science, and revolutionize cancer research and treatment by co-creating an open-source federation of federations platform. It will be developed using specific use cases focused on six major cancer types: Paediatric, Lymphoid malignancies, Pancreatic cancer, Ovarian, Lung, and Prostate cancers and active collaboration with a diverse range of stakeholders, including researchers, SMEs, industrial end users, and citizens. It will build on existing European RIs such as BBMRI as well as initiatives like EOSC4CANCER, CanSERV, EUCAIM, to enable seamless storage, access, sharing, and processing of data across Member States and associated countries. This approach will foster interoperability and collaboration, accelerating progress in cancer research. This action is part of the Cancer Mission clusters of projects 'Understanding' established in 2022.

The Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) have been introduced, replacing previous MD and IVD Directives to strengthen the EU regulatory framework, ensuring the highest levels of patient safety and smooth functioning of the single market for these products. Yet, this regulatory update comes with challenges arising from the increased regulatory burden and strain across various actors in the EU HealthTech value chain. To overcome these hurdles, in EU4MEDTECH, we will co-create (with an a-priori established Stakeholder Forum) and validate “EU4MEDTECH framework”, a versatile and life cycle-oriented set of methodological approaches, standardised models, and multi-domain criteria for the generation and evaluation of clinical and performance evidence of high-risk, innovative MDs and IVDs across pre-/post-market stages. An interactive, cloud-based digital platform will be designed and developed to operationalise EU4MEDTECH framework. The latter will include further features, such as a regulatory communication channel, a global regulatory search feature, a user training feature for EUDAMED stakeholders and a repository. EU4MEDTECH framework and recommendations for new common specifications, once integrated into the digital platform, will be evaluated within 3 different Use Cases (UCs). UC1 will focus on class III and implantable MDs, UC2 will target class C/D IVDs, whereas UC3 will focus on MD and IVD software (MDSW/IVDSW) and other highly innovative devices. 3 clinical studies will be performed in the context of UC3. Similarly, the digital platform will be evaluated through a Proof-of-Concept (PoC) study. Key MedTech stakeholders will be engaged in co-design throughout the project activities. A comprehensive exploitation roadmap will be developed to ensure that project results are widely and equitably adopted, scalable, and sustainable.