Europe – MDCG 2020-14 : Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the MDR/IVDR

Under the MDR/IVDR, most conformity assessment procedures consist of both the quality
management system audit and the assessment of a device’s safety and performance. Notified body’s conformity assessment activities, which are a prerequisite for the manufacturer’s declaration of conformity, when concluded successfully result in a conformity assessment certificate, a pre-market requirement for most classes of medical devices and IVDs. In that regard, notified bodies designated under the MDR/IVDR fulfil roles, which correspond to combined functions of both MDSAP auditing organisations and MDSAP participating regulatory authorities. Therefore, the roles performed by notified bodies and MDSAP auditing organisations differ as the latter solely perform quality
management system audits which are then utilised by regulatory authorities in their evaluation of a product’s safety and performance for the purpose of issuing a marketing authorisation…