Notified Bodies Can Use Single Audit Program Reports to Inform Surveillance

Notified Bodies that certify medical devices and diagnostics in Europe may use Medical Device Single Audit Program (MDSAP) reports for audits under the EU’s medical device and in vitro diagnostics regulations, a European Commission advisory group said.

Although the roles of MDSAP auditing organizations and Notified Bodies are different, the two complement each other, and Notified Bodies could use MDSAP reports to inform their audits, the commission’s Medical Device Coordination Group said in a new guidance.

MDSAP audit reports may be useful for Notified Bodies when planning required annual surveillance audits, the group said.