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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