Navigating Regulatory Compliance: Empowering Hospitals to Embrace 3D Printing

For many hospitals, the maze of regulatory compliance can seem overwhelming, often discouraging the adoption of cutting-edge technologies like 3D printing. However, the experiences shared by our expert speakers painted a different picture. Compliance and innovation can coexist harmoniously, ensuring both patient safety and the sustainability of 3D printing activities in hospitals.

An Vijverman of Dewallens & partners law firm kicked off the session with a detailed overview of the legal framework for 3D printing medical devices in hospitals. She demystified the legal qualification of 3D-printed medical devices and explained how custom-made devices, while exempt from CE marking, must still adhere to safety guidelines. Her insights reassured participants that regulatory compliance is manageable with the right knowledge and approach.

Francesco Moscato from the University of Vienna shared his experiences with in-hospital production and the legal challenges it entails. He highlighted the importance of clinical investigations and the complexities surrounding funding and reimbursement. Despite these challenges, his message was clear: hospitals can successfully integrate 3D printing into their patient care strategies with determination and the right support.

Koen Willemsen from UMC Utrecht provided a success story from an academic hospital setting. He detailed their journey to achieving ISO 13485 certification and implementing a robust quality management system (QMS). A key element is documenting all activities; a good case management system is a great help. His experience underscored the importance of separating clinical and production activities and highlighted how supporting other hospitals through knowledge sharing can elevate the entire healthcare ecosystem.

Hospitals implementing QMS and achieving ISO 13485 accreditation have seen positive outcomes. Rather than being feared, regulatory audits are opportunities for improvement and validation of high standards.

Experienced centers should actively share their knowledge and best practices. The 3D European SIG (special interest group) members are ready to mentor and guide new entrants, helping to establish more point-of-care centers across Europe.

Compliance should be viewed as a framework that ensures safety and efficacy, fostering an environment where innovation can thrive. Clinical consent and rigorous documentation remain critical components of the approval process.

In conclusion, the Leading Minds Summit underscored the immense potential of 3D printing to revolutionize healthcare. By focusing on the experiences of successful hospitals and fostering a collaborative approach, we can help more point-of-care labs embrace 3D printing. Regulatory compliance is not a barrier but a pathway to ensuring safe and continuous innovation in patient care. The roundtable discussions provided a clear message: starting 3D printing activities is not only feasible but also a must-do to improve patient care.