The upcoming deadlines for the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR) compliance do not solely affect medical device manufacturers. Pharmaceutical companies producing either combination products or companion diagnostics will also see their products undergo greater clinical scrutiny as laid down in these new regulations. Elizma Parry at Maetrics gives informative and practical guidance to pharmaceutical manufacturers who are new to the preparatory process and are required to obtain a CE mark for their device.