Navigate the transition to the new MDR and IVDR easily
Manufacturers are facing major and complex changes to the ways they currently manage compliance and, as a result, their manufacturing processes.
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. The summaries are taken from the full text MDR/IVDR Smart Support, which are exclusively available to Compliance Navigator subscribers.
This series includes background changes to:
- Unique device identification (UDI)
- Post-market surveillance
- Classification changes