Can MDSAP RAs void audits by an AO due to inadequate methods? If so, will manufacturers need another audit?

The MDSAP does not include mechanisms for requiring an audit to be re-done. Nevertheless, if an audit report appears to be unreliable, does not include a participating MDSAP jurisdiction in which the products are distributed, or does not include all the appropriate devices in the audit scope, an MDSAP RA may not be able to utilize the certificate or report as part of their process to grant a marketing authorization. A misleading audit report may also present a risk to public health and could lead the RAs to conduct their own follow-up inspection. Alternatively, an RA may request that an AO conduct a special audit to follow up on an issue. (IMDRF MDSAP WG N3 – clause 9.6.6.)

Manufacturers may forward a complaint with the MDSAP RAs in relation to an audit performed by an AO. The complaint will be processed using the procedure described in MDSAP QMS P0011.