What is the main safety concern with the revision? Could these changes actually make medical devices less safe?

Notified Bodies warn that several proposed cuts — no unannounced audits, less frequent reviews of safety reports, reduced documentation checks — would drop oversight below the standards that existed under the old pre-MDR/IVDR rules. Less checking doesn’t automatically mean fewer problems; it can mean problems go undetected for longer, with real consequences for patients. This is especially important for devices termed ‘medium-risk’. Medium-risk devices deserve the same consideration as others, due to their volume and the importance they play for all patients. Under the current system, the Technical Documentation for medium-risk devices is to be reviewed proportionally, with only 5 to 15% of medium-risk device groups to be reviewed by NBs. Under the new proposal this is proposed to be dropped to a single device. It is important to note that these device groups often have over 100 devices in them.
Additionally, it should be noted that especially medium and large sized manufacturers will benefit from this reduction of TD sampling. SMEs often only have one or two separate Technical Documentations that are already reviewed during initial certification, so SMEs would not benefit from this reduction of sampling.
This is of particular concern for IVD devices, or for devices used for patient tests. Given that each device will test multiple patients, the issue can therefore be compounded.