Europe – MDCG explains how notified bodies can use MDSAP audit reports

In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).
 
While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used to inform the scope and focus of surveillance audits performed by notified bodies.
 
“It is important to stress that the MDR/IVDR remain applicable in their entirety. 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,” MDCG writes.
 
With that in mind, MDCG adds that, “it could be possible to take into account the scope and outputs of manufacturers’ recent MDSAP audit reports as an input for developing surveillance audit programmes.” Doing so, MDCG says, could lead to more precise surveillance audits that are less focused on issues addressed by MDSAP audit reports…