Topic: In vivo optics (16:05 - 17:15)
TechMed Center, Twente University
Title: MDR regulations impact on photonics devices for healthcare
Many biophotonic devices originate from developments within research institutes. Due to the Medical Device Regulations (MDR), prototypes need to be produced according a QMS (like ISO 9001/13485) to get approval from an ethical committee to perform a clinical study to prove effectiveness. Flowcharts, guidelines and forms have been developed to support researchers to ease the preparation of the necessary documents and the transfer to medical companies towards CE certification. However, the capacity of ethics committees, clinical studies and notified bodies is limited. Consequently, we need to prevent that new biophotonic devices might not reach medical practice and current devices could be withdrawn in the next years.
Rudolf Verdaasdonk is chair Health Technology Implementation at University of Twente. With >30 year’s experience as clinical physicist and inventor, he advises researchers on the route from invention to product with MDR and clinical studies. He is member of the Central Committee on Research Involving Human Subjects (CCMO) and EU MDR expert panel.