EU MDR Economic Operators: Sharing Compliance Duties across the Supply Chain

The intricacies of the EU Medical Device Regulation (EU MDR) may still be unclear for many medical device manufacturers, notably the new requirements and implications related to Economic Operators (EO). The recent delay of the EU MDR deadline to May 26, 2021 is therefore a welcome development for the industry as it will allow businesses more time to prepare. In fact, a number of manufacturers are still in the process of confirming who qualifies as an EO and what their new obligations are under the regulation. Given the significant changes some of the new requirements represent, some EO entities may need to fundamentally alter their usual operations. This article highlights key aspects of these new responsibilities with the aim of helping businesses take advantage of the additional time.