NoBoCap - Notified Body Increased Capacity

The NoBoCap project is dedicated to strengthening the MedTech sector by enhancing the capabilities of Notified Bodies (NBs) and Market Operators (MOs). Its core objective is to streamline the intricate processes surrounding dossier submissions, reviews, and approvals. This way, innovative health solutions can reach the European market more quickly.

NoBoCap aims to bridge the divide between NBs, the Medical Device Industry (MDI), and MOs, fostering a collaborative environment that promotes efficiency and accessibility. The project's multifaceted approach includes targeted training programmes designed for both new recruits and seasoned professionals, focusing on high-priority topics relevant to MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) compliance.

A key component of NoBoCap is the development and implementation of a matchmaking platform. This platform is designed to connect MOs with NBs based on specific competencies and availability, facilitating efficient partnerships and reducing administrative burdens. The project also emphasises the creation of a community network comprising clusters, innovation hubs, and partners, fostering knowledge sharing and collaboration.

Through these activities, NoBoCap seeks to empower all stakeholders in the MedTech landscape. It helps improve the quality of dossier submissions and makes regulatory processes smoother, so new medical technologies can reach patients faster and more effectively. Ultimately, the project contributes to the advancement of healthcare across Europe by fostering a more efficient and responsive regulatory environment. NoBoCap's commitment extends to staying ahead of emerging technologies and their impact on MDR and IVDR regulatory requirements.

VITO's role in NoBoCap

VITO is responsible for “The NoBoCap short course on Performance evaluation of AI-based Medical Device Software (MDSW)”, using its expertise built up in the Vivaldy and REALM projects. This intensive training programme is designed to equip participants with essential skills and knowledge in the rapidly evolving field of AI-driven healthcare. 

The course covers crucial topics such as smart metric selection, confidence intervals, sample sizes, and the regulatory framework for AI-based medical devices in Europe. Participants, including notified body assessors, health technology assessors, and professionals from medical AI companies, gain insights into advanced model evaluation topics like bias, fairness, explainability, monitoring, and robustness. The course aims to enhance the ability of attendees to distinguish between well-evaluated and poorly assessed AI models, addressing common challenges and pitfalls in the assessment process.

Project partners

NoBoCap is coordinated by ROHEALTH, the Health and Bioeconomy Cluster.