Compliance Officer
Thea0Regulation (EU) 745\/2017 on Medical Devices (MDR)a0and thea0Regulation (EU) 746\/2017 on In Vitro Diagnostic Medical Devices (IVDR), require that manufacturers of Medical Devices and Authorized Representatives of Medical Devices and In Vitro Diagnostic Medical Devices, have aa0Compliance Officer.The Compliance Officer must have: either a university degree in medicine, law, pharmacy, engineering or another relevant scientific discipline and at least one year of experience in regulatory affairs or quality management systems related to medical devices, or four years of experience in regulatory affairs or quality management systems related to medical devices.
Manufacturers of Custom-Made Medical Devicesa0can demonstrate the expertise of the Compliance Officer by proving they have at least two years of professional experience in a relevant manufacturing field.Thea0Compliance Officera0must at least ensure that before releasing a product, its compliance is verified through the Quality Management System, that the technical documentation and the EU Declaration of Conformity are prepared and updated, and that post-market obligations, notifications, etc., are fulfilled.
Both regulations allow this service to be outsourced in small and micro enterprises.Thea0EUDAMEDa0database will reflect who performs these functions in each organization manufacturing Medical Devices or in the Authorized Representatives.deviCE Sistemas hasa0experienced personnela0knowledgeable in Medical Device and In Vitro Diagnostic Medical Device regulations, as well as thea0ISO 13485 quality management systema0and can efficiently offer the Compliance Officer service.
