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

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

In order to receive more infor­ma­tions on Guid­ance Doc­u­ments you might chose from the fol­low­ing options

• Browse our web­site by key­word guid­ance doc­u­ments.
• Vis­it our Com­plete Down­load Section.
• Read our para­graph “Major aspects of the MDR”.
• Read our arti­cle “Most impor­tant changes on MDR“.