Transitioning from Essential Requirements (ERs) to General Safety and Performance Requirements (GSPR): Unveiling Chapter III
With the transition in the European Union (EU) geography, from the Directives to the EU Medical Devices Regulations (MDR) 2017/745, significant changes have occurred in terms of rules and regulations. One such major change was observed in Annex I – General Safety and Performance Requirements (GSPR). In our previous blog, we deep dived into Chapter I and II. In this blog, we will analyze Chapter III and learn about additional details and Essential Requirements (ERs).