New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits

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The Medical Device Coordination Group (MDCG) has issued a guidance document that is intended to streamline audit processes and efforts under the medical devices regulation (MDR) and IVD regulation (IVDR).

The document explains to what extent and in which situations Notified Bodies may use audit reports issued under the Medical Device Single Audit Program (MDSAP) for MDR and IVDR surveillance audits. The 10-page guidance provides includes a reference table of MDSAP audit reports sections and what relevant information can be drawn from these sections for MDR and IVDR audits.

The document may be found here and in our complete download section.

Source: MDCG guidance

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