MDR: Regulating Devices That Don’t Have an Intended Medical Purpose

In late 2022, the EU Medical Device Regulation (MDR) was expanded by the addition of the common specifications (CS) 2022/20346. The spe00cifications describe the aspects that must be examined for devices without an intended medical purpose. These aspects apply in addition to the classical MDR requirements and include certain aspects of risk management. In other words, even products that only serve aesthetic purposes, such as colored contact lenses, will be assessed in accordance with the strict MDR regulations and, in addition, will have to fulfill the requirements laid down in the CS 2022/2346.