EU4MEDTECH
European Framework for Advanced Medical Technology Evaluation and Follow-up
Challenge
The Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) have been introduced, replacing previous Medical Device (MD) and In vitro diagnostic medical devices (IVD) Directives to strengthen the European Union (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.
Solution
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.
Objectives, Activities and Results expected / achieved
An interactive, cloud-based digital platform will be designed and developed to operationalise EU4MEDTECH framework. The latter will include four main features: 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.
Project Reference
Grant Agreement No 101191683Funding
Intervention Region
EuropeTotal Investment
7.676.743,75IPN Investment
599.993,75Total Eligible
7.676.743,75IPN Eligible
599.993,75EC Funding – Total
7.676.743,75EC Funding – IPN
599.993,75Duration
48 MonthsStart Date
2024-12-01End Date
2028-11-30Approval Date
2024-09-17Consortium
Sveuciliste U Splitu Medicinski Fakultet - University of Split School of MedicineKlinicki Bolnicki Centar Split - University Hospital of Split
Stelar Security Technology Law Research UG
Clinipower Finland Oy
University of Galway
Instituto Pedro Nunes
E.C.H.R. d.o.o. (NetHub)
Helsinki University Hospital Group
Fundacio Eurecat
Univerzita Komenskeho V Bratislave - Comenius University Bratislava
HUN-REN Institute for Computer Science and Control
Norwegian University of Science and Technology
Greek Patients Association
SGS Fimko Oy
Keywords
Health policy and services;Registries;
Risk Assessment;
Healthcare system;
Medical Devices;
In Vitro Diagnostic Medical Devices;
Medical Device Regulation;
In Vitro Diagnostic Regulation;
Health Technology Assessment.
