Health Technology Cluster iVita, together with other partners, has received funding for the implementation of the project “Notified Body Increased Capacity” under the call EU4H-2022-PJ-05, aimed at supporting increased capacity of Notified Bodies for medical devices. The planned project costs will exceed EUR 4.6 million. The project activities will involve 11 partners from different countries, including Romania, Belgium, Ireland, and Lithuania.
The project will cover the full scope of the call by involving key industry stakeholders, ensuring short- and long-term training objectives for participants, assessing current and future market needs, and addressing both MDR and IVDR requirements for in vitro diagnostic medical devices.
The project aims to positively influence Notified Body capacity challenges by directly training Notified Body and conformity assessment body staff on missing and emerging technologies. It will also train industry representatives through intermediaries on the expectations of Notified Bodies and conformity assessment bodies regarding submitted information and market access. This will help forecast capacity needs and train staff in advance.
These initiatives will improve technical knowledge within Notified Bodies, enabling faster adaptation to new technologies and reducing delays in the medical device approval process. They will also create more opportunities and visibility for professionals to move from industry to Notified Bodies, helping attract strong specialists.
As a result, both industry and Notified Bodies are expected to shorten technical and clinical assessment timelines, while Notified Bodies will strengthen their ability to attract human resources.
Considering the synergies between the initiatives, we are confident that this project will have a highly beneficial, sustainable, and controlled impact on Notified Bodies, conformity assessment bodies, market operators, healthcare professionals, and their patients.
The proposed activities will contribute to increasing the capacity of Notified Bodies, as well as improving the preparedness of market participants, especially SMEs, with particular attention to in vitro diagnostic medical devices.
