BfArM
The new article outlines specific requirements to be considered depending on the study type or design.
BfArM
The new article highlights the aspects related to applications for provisional admission for testing.
BfArM
The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
BfArM
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
BfArM
The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products.
BfArM
The new article addresses the matters related to interoperability for medical software products.
