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

 
• By Amanda Maxwell

This is the busiest time in the history of notified bodies as they try to process all manufacturers under the EU Medical Device Regulation (MDR). Making use of MDSAP audits is one way to cut down on work but is not always an option. The EU’s latest guidance explains the detail.

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What Is MDSAP And When Are the Reports Useful In The EU?

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.

A new 10-page EU guidance, MDCG 2020-14, has been published to inform EU notified bodies of how they can take into account Medical Device Single Audit Program (MDSAP) reports issued by MDSAP auditing organizations.

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