What is CE marking?

CE marking indicates that a product, including a medical device, conforms to the applicable EU legislation and can be placed on the European market. For medical devices this means meeting the general safety and performance requirements of the MDR or IVDR. For all but the lowest risk devices, a manufacturer cannot self-certify. Instead an independent conformity assessment body, called a notified body, reviews the technical documentation, quality management system, and clinical or performance evidence before the device may carry the CE mark. Notified bodies are designated and monitored by national authorities under EU oversight. The number of designated notified bodies and their available capacity has been a central constraint in implementing the MDR and IVDR, directly affecting how quickly devices can be certified and reach patients.