CMC


Types of reports for the implemen


Depending on the product’s class, there is two types of reports.

1.      Post-Market Surveillance report (PMSR)

Applied to class I MDR and classes A and B IVDR.

Requirements

-         Show results and conclusions from the PMS plan

-         Description of CAPA

-         Updated document

-         Available for Competent Authoritie’s revision (if needed)

-         In case of IVDR, the report should also be available for Notified Body’s revision.

2.      Periodic Safety Update Report (PSUR)

Applied to classes IIa, IIb and III MDR and classes C and D IVDR

Requirements

-         Show results and conclusions from the PMS plan

-         Description of CAPA

-         Conclusion of the benefit and risk

-         PMCF/PMPF

-         Sales volume

-         User population

-         Usage frequency

-         Update frequency

-         Annual update for classes IIb, III, C and D

This report should be in the Technical File of the device and be available for Notified Body as well as Competent Authorities revision.

The report should be reviewed by the Notify Body using Eudamed electronic system only if the device is class III MDR or class D IDVR.