Health technology cluster iVita with other 10 partners has received funding for the project “Notified Body Increased Capacity” (Call: EU4H-2022-PJ-05 Call for proposals to support increased capacity of notified bodies for medical devices). The project's estimated cost is more than 4,6 mln.EUR.

The project fulfils the full scope of the call by (1) incorporating the main stakeholders of the industry while at the same time considering the high levels of impartiality, (2) ensuring short- and long-term training goals for participants, (3) evaluating present and forecasted market needs and all this for (4) both MDR and IVDR (in vitro diagnostic medical devices).

Herewith, we will positively influence the NBs capacity issues by training NBs and CABs (conformity assessment bodies) staff directly on missing and upcoming technologies, by training through intermediates through the industry on the NBs and CABs expectations for submissions, and by pre-emptively capturing market needs so that capacity can be foreseen, and staff can be trained in advance. Respectively these initiatives will improve technical knowledge at the NBs allowing new technologies to be adapted quickly with fewer delays in the approval process and will ensure that there is greater opportunity and visibility for a career path for staff to transit from industry to NBs, providing strong professional pathways for industry candidates to meet the entry requirements for NBs. This will result in industry and NB reducing time on technical and clinical assessments and NBs can stay ahead of the curve when it comes to a pipeline of human resources.

Considering the synergies between the initiatives, we strongly believe this project will have a great impact on NBs, CABs, market operators, and healthcare professionals and their patients in a sustainable and controlled manner. The activities proposed will contribute to the increasing capacity of notified bodies and the preparedness of market operators, particularly SMEs, with a particular focus on IVDs.