The three-year transition period for the new Medical Device Regulation will end on 26 May 2020, and the new In Vitro Diagnostic Regulation will come into force in 2022. These new pieces of legislation bring changes to one of the pillars of the medical technology sector: the CE marking process. In this episode, we speak to Oliver Bisazza about what this process is, how it changes and what the medtech industry has to say about it.