As part of the transition to the new In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR), notified bodies such as BSI will be required to submit information related to applications, certificates, and other documents such as PSUR evaluation reports SSCPs (MDR) and SSPs (IVDR) to the EU database EUDAMED (European Database on Medical Devices). In order to comply with this requirement, BSI has implemented some changes to its operating processes and procedures which we would like to share with you.
