Presentation of individual case histories: This section of PSUR shall include the ind ...

Information required to be submitted for the in vitro diagnostic medical device: (1) ...

Discussion and overall conclusions The conclusions may include the following points:— ...

22.0 Information required to be submitted for the in vitro diagnostic medical device: ...

The parameters for classification of in vitro diagnostic medical devices as follows: ...

Procedural issues A system shall be established to enable cross-referencing of CRFs a ...

Other information: This section of PSUR shall include details about signals and Risk ...

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...