Author: Dr. Suzanne Broussard
Medical device manufacturers received clarification on how the European Commission’s Medical Device Coordination Group (MDCG) will allow Notified Bodies (NBs) to use Medical Device Single Audit Program (MDSAP) audit reports. The punch line of the MDCG 20-14 guidance document published in August 2020 is that NBs can possibly “take into account the scope and outputs of manufacturers’ recent MDSAP audit reports as an input for developing surveillance audit programs.”
MDCG stresses that the Medical Device Regulations (MDR) and In Vitro Device Regulations (IVDR) remain applicable in their entirety. Surveillance audits are mandated by law, as is their frequency, and the EU auditor’s competencies. Therefore, the “use of MDSAP audit reports is possible only where MDSAP audits covers similar of equivalent MDR/IVDR requirements.”
Canada mandates the use of MDSAP audits, and 4 other countries allow their use.
The MDCG 20-14 guidance now allows NBs in the European Union to take into account the manufacturers’ recent MDSAP audit reports’ scope and outputs as input for developing the surveillance audit program that defines more precisely the manner of the surveillance audit. Several examples are provided in which conformity of a positive quality management system through MDSAP might lead to a reduction of aspects already covered by MDSAP audit reports.
Non-exhaustive list of examples (in alphabetical order):
- Clinical evaluation/performance evaluation process (including post-market clinical/performance follow-up),
- EU authorized representative contractual provisions,
- EU UDI assignment with the quality management system,
- Manufacturer financial coverage in respect of potential liability,
- Person responsible for regulatory compliance qualification and role,
- Records control,
- System for risk management,
- Vigilance and post market surveillance activities, including the associated corrective actions and preventative actions.
The focused surveillance may allow NBs to specify MDR/IVDR requirements either not covered or only partially covered by the MDSAP audit report. Comparably, any non-conformities identified in a recent MDSAP audit report will likely trigger NB attention to those aspects in the MDR/IVDR surveillance audits.
The MDCG 20-14 guidance clearly states that the NBs are fully responsible for their decisions as to the use and to what extent they use the MDSAP audit reports. Note that MDSAP audit reports can only be presented to the NB for consideration during a regular surveillance audit. Manufacturers cannot use MDSAP for the MDR/IVDR initial quality management audits or unannounced audits.
The MDCG 20-14 also includes 2 Annexes.
Part I – Explanation of relevant information in MDSAP audit reports
Part II – Examples on how to correlations between MDR requirements to sections of MDSAP audit reports may be established.
The MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to provide improved medical device safety and oversight using a global approach to auditing and monitoring, and now the MDCG 20-14 guidance document provides NBs and medical device manufacturers with guidelines as to how MDSAP fits into the medical device regulations MDR and IVDR that will be in full application in the near future.
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