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Medical Device Single Audit Program (MDSAP)

Use of MDSAP audit reports in EU notified-body surveillance.

Official catalogue · non-binding

Medical Device Single Audit Program (MDSAP) guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
August 2020
Topics

Source document

  • MDCG 2020-14PDF · Unverified extraction previewOfficial source

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