Instituto Pedro Nunes joins European project to boost regulation of medical devices
General
RTD Laboratories
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Instituto Pedro Nunes (IPN) is part of the EU4MEDTECH - European Framework for Advanced Medical Technology Evaluation and Follow-up project consortium, a European initiative that aims to simplify and speed up the approval process for medical devices and in vitro diagnostic medical devices.
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The consortium is made up of 14 partners from 10 European countries, including universities, hospitals, patient organisations, consultancy firms and HealthTech accelerators.
EU4MEDTECH, funded by the European Union, has the main objective of developing an innovative digital platform that will serve as a complete and interactive guide for all stakeholders in the health sector, from manufacturers to regulators and health professionals. This digital tool will facilitate understanding of the new European regulations on medical devices(MDs) and in vitro diagnostic medical devices (IVDs) and provide a set of tools to help fulfill regulatory requirements.
IPN will play a crucial role in this project, leading two of the project's main workpackages (WP): WP2, responsible for laying the foundations for the development of an interactive digital platform, and WP5, focused on the development and implementation of this platform.
In addition, IPN will also contribute to various other tasks throughout the project, namely in the development of recommendations for common standards and in the definition of metrics to support evidence generation regarding MDs/IVDs' clinical efficacy, safety, and others.
The project's kick-off meeting took place on 3 and 4 December 2024 in Split, Croatia, marking the start of collaborative work between internationally renowned institutions.
EU4MEDTECH is a response to the challenges posed by the introduction of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), with a particular focus on the additional pressure on players in the medical technology value chain in the European Union. With a duration of 48 months and funding under the Horizon Europe programme (Call: HORIZON-HLTH-2024-IND-06), the project aims to develop an interactive digital platform with four main functionalities:
The evaluation of the platform will also be carried out through a proof-of-concept study, involving key stakeholders from the MedTech industry in the co-design of the solutions throughout the development of the project.
The EU4MEDTECH consortium includes, in addition to IPN, institutions such as the University of Split School of Medicine, University Hospital of Split, Stelar Security Technology Law Research, Clinipower Finland, University of Galway, Helsinki University Hospital Group, Norwegian University of Science and Technology, E.C.H.R. d.o.o., Fundació Eurecat, Comenius University Bratislava, Institute for Computer Science and Control, Greek Patient Association and SGS Fimko Oy.
Instituto Pedro Nunes (IPN) is part of the EU4MEDTECH - European Framework for Advanced Medical Technology Evaluation and Follow-up project consortium, a European initiative that aims to simplify and speed up the approval process for medical devices and in vitro diagnostic medical devices.
The consortium is made up of 14 partners from 10 European countries, including universities, hospitals, patient organisations, consultancy firms and HealthTech accelerators.
EU4MEDTECH, funded by the European Union, has the main objective of developing an innovative digital platform that will serve as a complete and interactive guide for all stakeholders in the health sector, from manufacturers to regulators and health professionals. This digital tool will facilitate understanding of the new European regulations on medical devices(MDs) and in vitro diagnostic medical devices (IVDs) and provide a set of tools to help fulfill regulatory requirements.
IPN will play a crucial role in this project, leading two of the project's main workpackages (WP): WP2, responsible for laying the foundations for the development of an interactive digital platform, and WP5, focused on the development and implementation of this platform.
In addition, IPN will also contribute to various other tasks throughout the project, namely in the development of recommendations for common standards and in the definition of metrics to support evidence generation regarding MDs/IVDs' clinical efficacy, safety, and others.
The project's kick-off meeting took place on 3 and 4 December 2024 in Split, Croatia, marking the start of collaborative work between internationally renowned institutions.
EU4MEDTECH is a response to the challenges posed by the introduction of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), with a particular focus on the additional pressure on players in the medical technology value chain in the European Union. With a duration of 48 months and funding under the Horizon Europe programme (Call: HORIZON-HLTH-2024-IND-06), the project aims to develop an interactive digital platform with four main functionalities:
- Regulatory communication channel
- Global regulatory search functionality
- Training functionality for EUDAMED stakeholders
- Regulatory information repository
The evaluation of the platform will also be carried out through a proof-of-concept study, involving key stakeholders from the MedTech industry in the co-design of the solutions throughout the development of the project.
The EU4MEDTECH consortium includes, in addition to IPN, institutions such as the University of Split School of Medicine, University Hospital of Split, Stelar Security Technology Law Research, Clinipower Finland, University of Galway, Helsinki University Hospital Group, Norwegian University of Science and Technology, E.C.H.R. d.o.o., Fundació Eurecat, Comenius University Bratislava, Institute for Computer Science and Control, Greek Patient Association and SGS Fimko Oy.
