Événement à la une
Du 30.01.2024 au 01.02.2024
Du 30 janvier au 1er février 2024, aura lieu à Paris le rendez-vous européen des acteurs de l'hydrogène.
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:
The Medical Device Regulation (MDR) and in vitro diagnostic medical device Regulation (IVDR) provides a new regulatory framework where reinforcement of clinical/performance evaluation of medical devices and IVDs, and in particular high-risk medical devices, is a key element. The confirmation of conformity with the relevant general safety and performance requirements set out in the MDR and IVDR is based on clinical data and its assessment (clinical/performance evaluation), including the evaluation of the acceptability of the benefit-risk- ratio. Within this new framework, the clinical/performance evaluation should follow a defined and methodologically sound procedure based on the critical evaluation of the relevant scientific literature, a critical evaluation of the results of all available clinical investigations/performance studies, as well as consideration of currently available alternative treatment options for the device under evaluation. Clinical/performance evaluation has to be updated throughout the life cycle of the device. Hence, clinical/performance evaluation can draw on multiple types of data including data from initial clinical investigations/performance studies and data gathered by the manufacturer's post-market surveillance system. To operationalise this new requirement, research is needed to help regulators develop common methodological frameworks (including common specifications) on the clinical evidence needed to demonstrate safety, performance and clinical benefit all along the life cycle of devices taking into account the type of device and clinical intended purpose.
Such methodological frameworks and standardised approaches are particularly needed for high-risk medical devices, e.g. implantable and class III medical devices, class C and D IVDs, medical device software (including AI enabled devices and next generation sequencing) and other highly innovative devices.
In order to address the differences between evidence generation for medical devices and IVDs, the project should be tackled taking into account those differences.
Proposals should address all of the following activities:
Proposals should build on relevant completed and ongoing initiatives in the field, in particular (but not restricted to) EU-funded initiatives. Proposals should involve researchers who are specialised in the clinical/performance evaluation of medical devices/IVDs and in the use of real-world data to evaluate medical products. Proposals should involve national competent authorities, notified bodies, IVD laboratories as well as Health Technology Assessment bodies and could involve patients’ representatives where relevant.
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
Article 49 – Coordination Group of notified bodies
Annex I General safety and performance
Mandatory applicable “technical standards” providing to the manufacturers means of proving conformity with the safety and performance legal requirements, issued by Commission as Implementing Acts.
building on previous initiatives such as PARENT, CORE-MD, JAMS
e.g. PARENT (PAtient REgistries iNiTiative) Joint Action, CORE-MD (Coordinating Research and Evidence for Medical Devices) H2020 research project, JAMS (Joint Action on Market Surveillance of Medical Devices) initiative