Conditional Certificates under the MDR/IVDR: Team-NB Statement on the Application of Specific Rules

Team-NB, the European association of Notified Bodies, has reinforced the importance of issuing certificates with conditions under the European Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). This approach allows innovative or orphan medical devices to obtain certification under specific conditions, such as more frequent post-market assessments, restriction of use to certain population groups or marketing limited to specialized medical institutions. Team-NB encourages Notified Bodies to apply this strategy to balance innovation and patient safety, ensuring faster access to new medical technologies.