In the European Union, the Medical Devices Regulation (MDR) has been in effect since May 2021, replacing the previous directives. Unlike the centralized system in the US, the EU system involves Notified Bodies that conduct conformity assessments for high-risk devices.
The MDR introduces more rigorous requirements for clinical data and redefines the classification system, though devices are similarly classified from low to high risk. Notably, the EU’s definition of medical devices excludes veterinary products, contrasting with the US where they are included.