The main changes introduced by the “MDSAP AU P0002.005 Audit Approach” document

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the former “MDSAP Audit Model” and “MDSAP Companion Document” by a unique combined one.

The new MDSAP audit approach document became effective immediately, with a transitional period until September 30, 2020 for audits already started on the date of publication of the document, allowing Auditing Organizations to train their auditors accordingly.

The main changes introduced are:

• A Statement was added to allow some flexibility to the audit sequence, subject to justification
• Clarified expectations on critical suppliers and outsourced processes
• Corrections were made on the duration for Brazilian “registration” and “notification”
• In the process “Measuring, Analysis and Improvement” the Task 14 (Evaluation of Complaints for Adverse Event Reporting) and Task 15 (Evaluation of Quality Problems for Advisory Notices) have been rewritten to eliminate perceived redundancy with tasks 1 and 2 of the “Medical Device Adverse Events and Advisory Notices Reporting” process.
• Reinforcement of requirements for Sterile Medical Devices during the audit in Annex 2
• New Annex 3 as a reference guide on declarations’ deadlines for adverse events and advisory notices to authorities
• New Annex 4 to specify the contract requirements with a specific focus on the contract between a manufacturer and the Australian sponsor