EU4MEDTECH
A comprehensive framework to support the lifecycle of innovative medical devices.
DURATION
48 months
(December 2024 - December 2028)
PARTICIPATING ORGANISATIONS
14
TOTAL BUDGET
7.676.743,75 €
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EU4MEDTECH
Project Partners
The EU4MEDTECH consortium unites 14 partners from across Europe, including universities, research institutions, hospitals, regulatory experts, and industry leaders. This multidisciplinary collaboration ensures a comprehensive approach to improving medical device evaluation and regulatory processes.
Each partner contributes to the research, development, validation, and implementation of the EU4MEDTECH framework, fostering a more efficient, standardized, and innovation-driven environment for medical technologies in Europe.
Project Coordinator
University of Split School of Medicine (MEFST)
Research-intensive medical school based in Split, Croatia. MEFST has participated in several projects involving new health technologies (MADE, SI4CARE) and brings expertise in training evidence-based medicine and reproducibility through numerous Horizon 2020 and Horizon Europe projects (EnTIRE, VIRT2UE, SOPs4RI, iRECS, iRISE, CHANGER).
Project Partner 2
University Hospital of Split (KBCS)
Health, research, and higher education institution in Split, Croatia, with a large patient/population capture in Croatia, as well as neighbouring countries. KBCS has participated in several EU funded projects within the FP7, Horizon 2020 and the EU4Health programs. KBCS’ scientific unit has experience in managing administrative tasks for clinical trials, including those of medical devices, and research ethics approval procedures. KBCS is the leader in HTA implementation in Croatia.
Project Partner 3
Stelar Security Technology Law Research (STELAR)
Based in Hamburg, Germany, specialises in technology law research, focusing on data protection within healthcare ICT. With expertise in legislation and fundamental rights, STELAR contributes to EU projects like OPERANDO, SOTERIA, SHiELD, and HEIR, along with initiatives such as PHArA-ON and DeepHealth. Active engagement with DIN, CEN, CENELEC, and ISO underscores STELAR's commitment to shaping standards in security, privacy, AI, and health informatics.
Project Partner 4
Clinipower Finland Ltd (CP)
Private consulting company and SME, specialising in supporting companies developing their MDSW products and operations to comply with an evolving regulatory landscape in the EU: adapting to both present and potential changes in regulations. CP is member of the health-tech industry association in Finland. CP is a partner in the EU’s Managidith program85, part of the Digital Europe programme and managed by HADEA.
Project Partner 5
The University of Galway (UOG)
University located in Galway, Ireland. UOG is the home of the CÚRAM, a world-leading research centre designing the next generation of ‘smart’ medical devices.
Project Partner 6
Instituto Pedro Nunes (IPN)
Non-profit association established and located in Coimbra, Portugal. The Laboratory for Automation and Systems (IPNlas) specialises in Edge Artificial Intelligence, collaborative robotics, and Medtech and Digital Health (with a focus on Telemedicine and Homecare). The laboratory includes a unit that supports manufacturers in regulatory affairs and in obtaining medical device certification. IPN's proven track record is highlighted by its involvement in projects such as AAL, TEF-Health, DigitalHealthPT, and HealthfromPortugal.
Project Partner 7
NetHub (NEHU)
HealthTech accelerator based in Croatia that actively supports entrepreneurs and researchers in maturing their collaborative ventures with commercialization potential. Through its participation in initiatives such as the EIT Health Drive program, NetHub has occupied roles in various projects, ranging from coordinator to participant (development of the entrepreneurial accelerator for healthcare technologies – ERDF co-funded project, Digital literacy enables up-to-date sleep medicine in inclusive healthcare (Erasmus+), EIT Health Drive programme, H2Hub, SI4CARE, etc).
Project Partner 8
Helsinki University Hospital (HUS)
Public hospital located in Finland. HUS is a pioneer in user-centric digital services and data-based solutions to support predictive personalised care, demonstrated by activity in multiple EU-projects (HARMONY, AICCELERATE, ONCOVALUE, PHEMS) and EU-based real-world data collaborations (DARWIN, HONEUR). HUS specialises in advancing healthcare innovation through clinical trials and collaborative initiatives, emphasising personalised medicine and digital health.
Project Partner 9
Eurecat (EUT)
Non-profit foundation in Catalonia, Spain, that excels in digital technologies, notably in health and cybersecurity projects such as ACE, KATY, and ALTERNATIVE. Leveraging its expertise in IoT/IoM security and regulatory compliance, EUT's IT&OT Security Technology Unit has driven innovation in H2020, Horizon Europe, and national projects across diverse sectors.
Project Partner 10
Comenius University in Bratislava (UNIBA)
University based in Slovakia which in 2019 celebrated its 100th anniversary. UNIBA has participated in several EU projects involving HTA (ASCERTAIN, EUNETHTA JA3, HEcoPerMed) and brings expertise in HTA, pricing and reimbursement decision making.
Project Partner 11
HUN-REN Institute for Computer Science and Control (SZTAKI)
Centre of Excellence in Information Technology, Computer Science and Control of the European Union since 2001. Since 2010, SZTAKI hosts the Fraunhofer-SZTAKI Project Centre for Production Management and Informatics (PMI). Between 2020-2025, SZTAKI coordinates the Artificial Intelligence National Laboratory Hungary, in which medical and health applications play key role and has participated in several projects such as FARADAI (EDF 2021); BuildChain (HE CL4); STREAMLINE (H2020).
Project Partner 12
Norwegian University of Science and Technology (NTNU)
Largest higher education institution in Norway. The unit that is involved in the project leads the Norwegian Research for AI Innovation, a coordinator for research and innovation activities among universities, research institutions and companies working in the field of AI, ML, and learning technologies.
Project Partner 13
Greek Patients Association (GPA)
Union of over 70 patient organisations across the spectrum of disease. The association is an umbrella non-profit organisation that provides support, advocacy, and capacity building for its members and patients. GPA is a member of the European Patients Forum. GPA specialises in enhancing patient engagement and representation in healthcare policy and MDR, with a dedicated team committed to ensuring that patient perspective is central to healthcare innovation and policy.
Project Partner 14
SGS Fimko Oy (SGS)
Finnish member of the global SGS Group, is a NB for MDR that offers expert certification, testing, and inspection services. Specialising in ensuring compliance with rigorous quality, safety, and regulatory standards, SGS Fimko's MDR unit will be participating in the EU4MEDTECH project, contributing its expertise to the advancement of MD and market readiness.
The EU4MEDTECH Team
The EU4MEDTECH project is led by a team of experts in medical technology, regulation, clinical research, and patient advocacy. We are committed to improving the evaluation and regulation of high-risk medical devices and in-vitro diagnostic medical devices to benefit patients and healthcare systems.
