Classification and device facts
Confirm source facts, understand warnings and distinguish provisional from released work.
5 guides
Review extracted device facts and lock the fact setUse the action shown for each fact, then lock the set so your expert can sign off.Understand a class-raise warningRead the warning before submitting an answer that may raise the device class.Read a provisional classificationKnow why a displayed class is not released until facts and expert sign-off are complete.Review IVDR intended useConfirm the intended-use facts that govern an IVD's classification and description.Complete the device description wizardReview the generated description, correct its facts and produce the available PDF record.