Medical device and diagnostics manufacturers are likely to face huge challenges to implement the new requirements imposed by the new European Medical Device Regulation.
Compared to the MDD, MDR 2017/745 introduces a life-cycle approach to ongoing CE Marking compliance. Conformity assessment procedures are more complex, and equivalence will be more rigorously interpreted.
Clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require recurring updates. Manufacturers must also fulfill increased post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies, and deliver Period Safety Update Reports. Transitioning to the MDR might seem overwhelming and many companies don’t know where to start.
Stefan Menzl, Principal Consultant at Qserve, presented key guidance and interpretation of the changes to the regulation at the 4th European Conference on Clinical Research organized by EUCROF in Vienna on 26 & 27 February 2018.
"It was a very successful event, I am looking forward to meeting you during future events. Contact me if you want to discuss further."