The Medical Device Single Audit Program (MDSAP) has released an updated version of its Technical Review and Recognition Decision Procedure (MDSAP AS P0017.005), effective 1 September 2026.
This procedure applies to a technical review process that is to occur after each complete assessment of the AO (Initial, Surveillance, Re-recognition, Witnessed), when the escalation of nonconformities is deemed necessary in accordance with the AO nonconformity procedure, and prior to the imposition, removal or variation of a condition on a recognition decision.
This procedure also applies to a review and decision process that is to occur after initial recognition or re-recognition assessments, for an extension of scope, for a restriction of scope due to a safety issue, or, in cases of fraud due to misrepresentation or the falsification of evidence, due to the escalation of nonconformities, and for the imposition, removal or variation of a condition.