MDSAP reports provide a detailed assessment of a manufacturer’s (QMS) compliance to ISO 13485 requirements and many other regulatory requirements similar to certain MDR/IVDR requirements.
It would be a significant benefit when Notified Bodies can apply the MDSAP model in MDR/IVDR audits. So what do the current regulations and guidance documents say?
The EU Medical Device Regulation (MDR 2017/745) / In Vitro Diagnostic Regulation (IVDR 2017/746) requires that manufacturers establish a Quality Management System (QMS) to ensure device manufacturing comply with MDR/IVDR requirements. The MDR/IVDR states that Notified Bodies identify audit activities required to demonstrate complete coverage of a manufacturer’s QMS and that surveillance audits need to be carried out on (at least)
yearly. Surveillance audits must gather sufficient information to verify proper QMS implementation.
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to establish a single audit program for conducting QMS audits based on ISO 13485:2016 and including the regulatory requirements of the participating jurisdictions (currently Australia, Brazil, Canada, Japan, and the USA).
Although the European Union (EU) is not (yet?) participating in MDSAP, there is a strong interest of an Auditing Organization - often also EU Notified Body for the same manufacturer - to (re-)use MDSAP audits reports in EU regulations audits to increase efficiency and consistency in their auditing activities and outcome.
Use of MDSAP Audit Reports under MDR/IVDR
The Medical Device Coordination Group Guidance (MDCG) released in august 2020 a guidance document (MDCG 2020-14) titled “Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)”. This guidance document stipulates that:
- Recent MDSAP audit reports may be taken as an input for developing EU regulatory surveillance audit programs but only in their complete form, thus including the positive and negative statements. Please note that the use of MDSAP audit reports does not apply to initial, unannounced or special (or for cause) audits.
- Regular surveillance audits would still take place yearly, however, a positive QMS conformity appraisal through an MDSAP audit may lead to a limitation of the surveillance focus.
- In case of serious concerns (e.g., from vigilance cases, Post Market Surveillance data, or Technical Documentation assessment), complete surveillance audits are still always mandatory.
- MDR/IVDR requirements remain applicable in their entirety. The use of MDSAP audit reports within the EU legislative framework is possible only where the MDSAP audit covers similar or equivalent MDR/IVDR requirements.
- Notified Bodies maintain still the full authority over their judgment, conclusion, and the final decision about the conformity of QMS to the relevant provisions of the MDR/IVDR and the safety and performance of medical devices/IVDs intended to be placed on the EU market.
Be aware that - on the other hand - nonconformities identified in recent MDSAP audit reports could trigger the Notified Body for additional areas of attention in EU regulatory surveillance audits.
The MDSAP Model can be applied in MDR/IVDR audits under the circumstances and with the limitations as outlined in this blog. Manufacturers with MDSAP reports may benefit from increased efficiency and consistency of their Notified Body auditing activities in conducting surveillance MDR/IVDR audits. However, it does certainly not wave the manufacturer to comply with any of the applicable MDR/IVDR requirements.
MDSAP reports are not allowed to be used for initial audits, but Notified Bodies can still offer a combined audit, i.e., both MDSAP and MDR/IVDR in 1 (extended) audit.
CLICK HERE TO DOWNLOAD
Free Webinar | MDR/IVDR Auditing with a MDSAP Model presented by Henk-Willem Mutsaers