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Regulatory Focus™ > News Articles > 2020 > 8 > MDCG explains how notified bodies can use MDSAP audit reports

MDCG explains how notified bodies can use MDSAP audit reports

Posted 10 August 2020 | By Michael Mezher 

MDCG explains how notified bodies can use MDSAP audit reports

In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).
 
While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used to inform the scope and focus of surveillance audits performed by notified bodies.
 
“It is important to stress that the MDR/IVDR 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,” MDCG writes.
 
With that in mind, MDCG adds that, “it could be possible to take into account the scope and outputs of manufacturers’ recent MDSAP audit reports as an input for developing surveillance audit programmes.” Doing so, MDCG says, could lead to more precise surveillance audits that are less focused on issues addressed by MDSAP audit reports.
 
“The notified body may then focus their surveillance audit on specific MDR/IVDR requirements which are either not covered or only partially covered by the MDSAP audit report,” MDCG writes, such as clinical evaluation and performance evaluation processes and EU unique device identifier assignments.
 
On the other hand, MDCG says that nonconformities raised in MDSAP audit reports, “Can trigger the notified body to pay particular attention to those aspects in the MDR/IVDR planned surveillance audit.”
 
MDCG notes that MDSAP audit reports should not be used for initial quality management system audits required for EU QMS certificates, and that reports from unannounced MDSAP audits or special audits, “Should not be taken into account in narrowing of focus in MDR/IVDR surveillance audits.”
 
Additionally, MDCG stresses that MDSAP audit reports should be considered in full, including all associated attachments, when being used to plan MDR/IVDR surveillance audits, and says that complete surveillance audits should be carried out if there are any concerns about the functioning of a company’s quality management system.
 
The guidance also includes two annexes explaining where MDR/IVDR-relevant information can be found within MDSAP audit reports and providing examples of how MDR requirements for clinical evaluation, supplier controls and postmarket surveillance and corresponding sections of MDSAP audit reports can be linked.

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