Which impact have the reduced surveillance activities of notified bodies as proposed in the draft MDR and IVDR?

Beyond the concern noted in A3, patient safety may be compromised under the new MDR/IVDR proposal, as manufacturers lacking evidence of device safety and effectiveness could go undetected. Notified Body oversight is significantly reduced; technical documentation is assessed only “for cause,” surveillance audits are less frequent, unannounced audits depend on specific concerns, and no independent review is required for safety reports or updates such as Summary of Safety Clinical Performance (SSCPs) and Periodic Safety Update Reports (PSURs).