NoBoCap

TU Dublin is a partner in NoBoCap (Notified Body Increased Capacity), a ground-breaking initiative under the wings of the EU4Health Programme.

The project is committed to fostering a conducive environment for swift and efficient advancement in the Medical Technology (MedTech) sector. The mission is to bridge the gap between Notified Bodies (NBs), the Medical Device Industry (MDI), Market Operators (MOs), and other players streamlining the complex process of dossier submissions, reviews, and approvals. By increasing accessibility and enhancing capacities, we are working to ensure that innovative health solutions can reach the market more swiftly and efficiently.

TU Dublin Principle Investigator Dr. Graham Gavin from the School of Mechanical Engineering explains:

"As part of the NoBoCap project, the University has a role in accrediting Master's Level courses that are offered primarily to individuals from MedTech SMEs across the EU. The courses have a unique offering in that they are designed and delivered by expert practitioners and trainers from Notified Body SGS." 

The courses will guide learners to a greater understanding of regulatory requirements and improve technical documentation submission, a critical step in getting a medical device onto the EU market.

Three modules have been developed by knowledge experts Notified Body SGS and accredited at NFQ Level 9 (EQF Level 7) in TU Dublin, Ireland and TG Mures, Romania.

• Module 1: Implementing Regulatory Requirements for Medical Devices
• Module 2: Generating Data for Technical Documentation (MDR)
• Module 3: Generating Data for Technical Documentation (IVDR)

To date, over 215 learners from across the EU have registered onto the CPD programmes in TU Dublin. These will continue to be available throughout 2025 in one of the host universities. 

There are also a number of short courses available through our partners:

• Training for C-level Management - MDR/IVDR Implementation and Resource Allocation
• AI-supported Medical Devices

In addition, a range of e-tools have been developed by partners to assist with medical device classification and in identifying applicable codes. 

To find out more information on the NoBoCap project, visit: https://nobocap.eu/

To express interest or register for upcoming courses, visit: https://portal.nobocap.eu/

Please connect on social media for updates:

• Facebook: https://www.facebook.com/nobocapproject
• LinkedIn: https://www.linkedin.com/company/nobocap-project