EU Guidance Explains How And When MDSAP Audits Can Offer Auditing Shortcuts

The Medical Device Single Audit Program (MDSAP) allows manufacturers to have their medical device quality management system audited once as testimony that it meets the quality system regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the US.

As would be expected, the use of MDSAP audit reports within the EU legislative framework is possible only where the MDSAP audit covers similar or equivalent MDR/IVDR requirements.

Whatever is contained in the MDSAP report, notified bodies have the full authority over their judgement, conclusion and final decision about the conformity of quality management systems under the MDR/IVDR and the safety and performance of medical devices and IVDs intended to be placed on the market in the EU.