Theme Surveillance audits MDR / MDSAP
Target audience Notified Bodies (NB)
Products concerned MD, IVD



Regulatory references

MDR (EU) 2017/745

Recital 32

Article 10(9)

IVDR (EU) 2017/746

Recital 31

Article 10(8)

Documents mentioned MDSAP Audit reports

MDSAP Audit report form guidelines


This MDCG guidance explains how, if the manufacturer wishes so, the NB can take MDSAP audit reports into account when planning surveillance audits under the MDR or IVDR.

Beyond this possibility, the guide provides information which may for example help manufacturer to structure internal audits through :

  • MDCG’s opinion on the requirements of regulations that are not covered or partially covered by ISO 13485
  • A table of correspondence indicating which parts of the MDSAP report may contain information relevant to the quality management system audits (MDR / IVDR)
  • 3 examples of correlations between the requirements of the MDR and the sections of the MDSAP audit reports (Clinical evaluation, control of subcontractors, post-marketing surveillance)