The open call – offered in the framework of TBMED – is addressed to help developers in the development of high-risk medical devices class IIb and III (In vitro diagnostics excluded) with a focus on, prevention, monitoring, prediction, prognosis, diagnosis, treatment or alleviation of disease, injury or disability of patients that fall into the following healthcare areas (but not limited to):
- Wound management
This call is supporting developers to perform clinical investigations. The selected projects should present innovative solutions, ready to perform clinical investigations in humans with solid scientific and technological background, including all preclinical validations needed and a defined indication. This call is focused on those medical devices with enough progression in their development to be tested in the relevant clinical environment (TRL-6, proof of concept, or TRL-7, clinical investigation) helping them to progress to higher TRLs4. Therefore, only medical devices with a minimum TRL of 5 will be considered in the current call.
For developers which aim to perform a multinational clinical investigation in at least two of the ECRIN
member/observer countries (ECRIN member and observer countries: Czech Republic, France, Germany,
Hungary, Ireland, Italy, Norway, Poland, Portugal, Slovakia, Spain, Switzerland):
- Consultancy for the development of multinational clinical medical device investigations (minimum two European countries involved from the list mentioned above)
- Clinical Investigation Methodology – Validation of clinical investigations through
- independent protocol peer-review
- Regulatory and ethical requirements for clinical investigation authorization
- Clinical investigation operational planning
- Support for multinational pivotal clinical investigations in order to determine performance of a medical device including central services (Project Management, Regulatory and Ethical Submissions, Data Management and Statistics, Global Materiovigilance) and distributed services (Local Monitoring, Local Materiovigilance, and Local Project Management)
TBMED is an EU-funded collaborative research project which aims to increase patients’ access to high-risk medical devices, by helping SMEs to minimize time-to-market and the reimbursement process time, thus optimizing the process of transforming a prototype into a valuable innovative MD.