In compliance with the IVDD (In Vitro Diagnostic Directive), we would like to clarify that a Person Responsible for Regulatory Compliance (PRRC) is not required under this directive. As such, our organization currently does not have a designated PRRC under IVDD. However, we are aware that this requirement will change under the upcoming IVDR (In Vitro Diagnostic Regulation), and we are taking the necessary steps to ensure full compliance by the applicable deadlines.