The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and Australia. Although this program does not cover the requirements of the EU, which is the EU MDR and IVDR, a guidance document released by the MDCG (Medical Device Coordination Group) explains the use of MDSAP audit reports by the notified bodies when performing surveillance audits under the EU MDR and IVDR...

1. MDSAP Reports for EU Surveillance Audits
By: Nikita Angane
The MedicalDeviceSingle Audit Program coversthecompliancerequirementsof theUSA,
Brazil, Japan, Canada, and Australia. Although this program does not cover the requirements of
the EU, which is the EU MDR and IVDR, a guidance document released by the MDCG (Medical
Device Coordination Group) explains the use of MDSAP audit reports by the notified bodies when
performing surveillance audits under the EU MDR and IVDR.1
Howcan MDSAP Audit reports be used to establish conformance to EU MDR/IVDR?
Theguidancedocumentexplicitly mentionsthattheEU MDR andIVDRremainapplicable
in their entirety and MDSAP reports can only be considered where the MDSAP audit covers
similar or equivalent MDR/IVDR requirements. For example, requirements of the MDR such as
the Clinical Evaluation Plan and the required procedures to keep up to date with the clinical
evaluation plan are not covered under the MDSAP audit and therefore must be audited by the
notified body to assess conformance of the organization to this requirement.1
The results of an organization’s MDSAP audit may be used to formulate the audit plan of the
surveillance audit. This may focus on the specific aspects of the EU MDR/IVDR such as CERs,
authorized representative requirements, etc if the MDSAP audit results are found to be
satisfactory by the auditor.1 However, the notified body auditors have the right to exercise their
judgment and make conclusions about the conformity of the QMS.
It is important to note that the MDSAP audit report will not be considered under the following
circumstances:1
 Initial QMS audits - which are required for EU QMS certificates and will always be
conducted in their entirety
 MDR/IVDR unannounced audits
An unannounced MDSAP audit report or a special audit report cannot be considered under this
program.1
The notified body is fully responsible for deciding on whether the MDSAP audit report can be
considered in the MDR/IVDR surveillance audit.1 Are you transitioning to the new EU
regulations?Ortrying toget yourMDSAPcertificate?EMMAInternationalhastherightexpertise
to help you. Call us today at +1 248-987-4497 or email us at info@emmainternational.com
1 MDCG (Aug 2020) Guidance for notified bodies onthe use of MDSAPaudit reports in the context of surveillance audits carried
out under the Medical Devices Regulation(MDR)/InVitroDiagnostic medicaldevicesRegulation(IVDR)retrieved on
01/03/2021 from https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf