Smart Support Series Landing Page

To help you understand the background changes of the new Regulations so that you can prepare for the navigation to the MDR and IVDR, BSI Compliance Navigator has published the Smart  Support Executive Summary Series. Please click the link below to be redirected to download the series' listed below:

  • Clinical Data, Clinical Identification and Clinical Investigation
  • Authorized Representatives, Responsible Persons and Importers, Distributors and Assemblers
  • Unique Device Identification (UDI), Post-Market Surveillance and Classification Changes