Updates
The content has been updated on the following pages:
Manufacturers / Step 7. Register the device and the manufacturer Updated links to the EUDAMED actor registration module and MDCG guidance on UDI.
Manufacturers / Step 1. ... / Classification Added link to MDCG guidance on the classification rules for IVDs and on software qualification and classification.
Manufacturers / Step 2. ... / Vigilance compared to the IVDD Update links to additional guidance on MEDDEV 2.12/1 rev.8 July 2019 and Manufacturers incident report (MIR) as from January 2020.
Archive
The following pages remain accessible but are no longer being updated. As a result these pages may contain out of date information:
This list is empty.