To gauge how the EU Medical Device Regulation will affect markets outside the EU that use it as a regulatory standard, it is necessary to understand how those countries currently use the EU Medical Device Directive.
Assessing the impact of the changes that will arise in non-EU markets after 26 May is a subject that preoccupies MedTech Europe (MTE) and its director of general strategies, special projects and international affairs, Jesús Rueda Rodríguez
There are fundamentally two levels of impact, he explained. The first is labeling, where the MDR introduces new labeling provisions. MDR- and MDD-regulated products will have different labels