The regulatory world has had a huge upheaval in the last few years, starting back before the COVID-19 pandemic with the publication of the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Even with the delay of the implementation of the MDR by a year, it has been an incredible drain on resources globally, often pulling the best talent within organisations into MDR transition project teams and restricting growth in non-EU regulatory functions due to budget constraints in an uncertain period for many companies due to COVID-19.
The impact on medical device companies cannot be overstated, and the resource and ...