• Transitioning from ER to GSPR - Part I of Part II

    The European Union Medical Device Regulation (EU MDR) has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directives (AIMDD), introducing several significant changes in the regulations. One of the key elements that has been replaced is Essential Requirements (ER). ER have now been replaced by General Safety and Performance Requirements (GSPR). Although it might seem that both lay out the same requirements, GSPR lays out more stringent requirements. For instance, under GSPR, manufacturers are now required to demonstrate and analyze more clinical data.

  • Revisiting the EU MDR Timeline Extension

    The European Union's (EU) Medical Device Regulation (MDR) has been making news for a while now. The MDR has replaced the Medical Device Directive (MDD) and Active Implantable Device Directive (AIMDD). Initially, the entire transition was set out to be in complete effect by May 2020; however, due to the emergence of the COVID-19 pandemic, the implementation was pushed further to May 26, 2021. In this timeline, by May 26, 2024, all the MDD certificates will become void, and the device manufacturers will be required to conform with the EU MDR.