The New EU: IVDR (In Vitro Diagnostic Medical Devices Regulation) and Economic Operators

The New EU: IVDR (In Vitro Diagnostic¬†Medical Devices Regulation) and Economic Operators Mike Andrews, Ph.D., Vice President Regulatory and Quality, Boulder iQ, Boulder, Colorado Introduction The EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will replace the EU In Vitro Diagnostic Medical Devices Directive 98/79 (IVDD).¬† Compliance with the IVDR is required no later […]