Prof. Dr. Folker Spitzenberger

Professor for regulatory affairs and quality management for medical devices at the University of Applied Sciences, Luebeck, Germany. Since 2005 until he has been working as a(n) consultant, scientific expert, advisor for WHO, EU, PTB and other organizations in numerous international projects related to regulatory affairs, quality assurance, quality management, biosafety/biosecurity, accreditation/certification and standardization of medical/health laboratories. He has International work experience as senior scientist, quality assessor and quality expert for all kinds of quality systems related to the in vitro diagnostic medical devices (IVDMD) sector including branches as accreditation and designation, certification and GMP, risk assessment and vigilance, disease control and prevention. 

New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills. The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified Bodies. In short, they have a lot more work to do and need to recruit new expertise and upskill existing team members. In 2012, there were 87 Notified Bodies. Since then this number has fallen to 58. Now, they need to be designated under the new Regulations and it has become clear that not all will reapply – and, for those that do, not all applications will be successful. In terms of demand for their services, the only way is up. Additional and stringent requirements mean an enhanced role for Notified Bodies. Some products that were not subject to conformity assessment and post-market surveillance before, notably a large volume of IVDs, will now require much closer scrutiny. There are too few appropriately-staffed Notified Bodies to absorb the workload that is about to land on their desks. For many manufacturers, this will make it challenging to obtain certification under the Regulations. This uncertainty is bad for business, especially smaller players. For patients and health services, it risks delaying or discontinuing access to medical technology products. To address a clear long-term need for new skills, the Lübeck University of Applied Sciences is offering an online MSc in Regulatory Affairs for professionals in the medtech field. While this may not solve the short-term challenges, it can help strengthen the system in the years ahead. To me, this is a really exciting opportunity to bring expertise in regulatory affairs and biomedtech sciences to those who need it. Our faculty...