EU4MEDTECH

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.