How Are Medical Devices Classified Under EU MDR?

The European Commission (EC) introduced new regulations in 2017 known as the EU MDR 2017/745, which replaced the existing Medical Device Directive (MDD). Under the EU MDR changes, medical devices must now receive a CE marking to be legally sold in the EU.

To obtain this prestigious mark, a thorough conformity assessment must be carried out based on the device’s risk class to ensure that all applicable regulations required by the MDR are met.

Medical Devices Classified Under EU MDR