General safety and performance requirements (GSPR)
A vital part of MDR and IVDR
In May 2017 EU introduced two new regulations for medical devices; Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
MDR is applicable from May 26, 2021 and IVDR from May 26, 2022.
All manufacturers and authorized representatives shall have a Person Responsible for Regulatory Compliance (PRRC) available within the organization (see below for more info).