PRACTICE NOTES
This Practice Note explores the European database on medical devices (EUDAMED) and the obligations on economic operators, including manufacturers, distributors and importers of medical devices, arising under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). For guidance on:
key provisions of the MDR and IVDR, refer to Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
clinical evaluation and investigation of devices, consult Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU
post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the
Life Sciences