MDSAP "Audit Approach" published

The MDSAP Council published the new "Audit Approach": MDSAP AU P0002.005.
This document is combining the previous "Audit Model" and the "Companion Document" into a single source.


At the same time the new "audit approach" replaces the previous documents latest 2020-09-30.


It is important to notice that the text of the "audit tasks" and "criteria" have not been changed.


The new document now includes 2 new annexes with further information concerning the national legislation of the member countries:


Annex 1

  • contains country specific information as to the expectations for the audit of product / process related technologies (other than sterilization – See Annex 2) and the audit of technical documentation as part of the execution of the Audit Tasks

 Annex 2

  • contains information as to the expectation for the audit of requirements for sterile medical devices.

Annex 3

  • contains a table showing a summary of timeframes for reporting advisory notices and individual adverse event reports in the participating MDSAP jurisdictions.


  • contains country specific guidance on expectations for various types of written agreements for regulatory purposes.