The MDR is going to change life as we know it. Just compare the times the words “safety” and “clinical” appear in the MDR compared to the MDD: safety 290 times vs 40, “clinical” 650 times vs 100. Clinical aspects of CE marking are no longer “reserved” for the clinical/medical department, but should be addressed on a company level. Furthermore, the demonstration of clinical safety is no longer confined to the preparation of a clinical evaluation report in the development phase. Instead, the MDR extends clinical aspects throughout the product lifecycle. It is therefore of paramount importance to have a cross-functional approach, involving various departments and functions, that starts at the concept phase and ends at product-discontinuation. Companies must adapt their product development processes and post-market processes to the new requirements in the MDR. The request for new documents not only leads to new processes & SOP’s but to new competences and responsibilities as well. The clinical team should be able to guide, interact and communicate with all stake-holders hence becoming a promotor of clinical safety in the company, from the concept phase, all the way to product-discontinuation. This new role requires a different team and a different approach to clinical safety. In this talk, our approach to organizing the appropriate team is demonstrated, touching on pitfalls and opportunities as well as costs and benefits.
Edo Knijff, born in the Netherlands, combines a strong scientific background with Regulatory and R&D experiences. Originally a Biotechnology graduate, he started as a researcher at the University of Verona, Italy, publishing several papers on antibiotic resistance of bacteria. After a few years, he started in the Regulatory Affairs department of Orthofix SRL, in Verona. There, he was responsible for 510K clearance and CE marking of their products, working closely with not only R&D but also with FDA and Notified Bodies. Since 2007 he heads the Clinical Affairs Department. Apart from clinical studies, he is also involved in the development of new products. Since the release of the first draft of the MDR, he and his team have been involved in the gap-analysis and action plan to be aligned with the new requirements of the MDR.