Basic-UDI-DI-MCQ Welcome to your Basic-UDI-DI-MCQ Name Email 1. What is the primary purpose of the Basic UDI-DI under the MDR? To identify individual units of a medical device. To serve as the main identifier for a device model. To track the manufacturing date of a medical device. To provide information about the device's packaging. None 2. Which of the following factors would necessitate a change in the Basic UDI-DI? A change in the device's packaging configuration. A change in the device's intended use. A change in the device's manufacturing location. A change in the device's shelf life. None 3. The Basic UDI-DI is assigned at which level? The individual device level. The production batch level. The device model level. The shipping container level. None 4. Which database is used for registering Basic UDI-DI information in Europe The FDA's GUDID database. The EUDAMED database. The WHO's Global UDI database. The manufacturer's internal database. None 5. Does the Basic UDI-DI need to be present on the device label? Yes, always. No, it is not required on the label. Only for Class III implantable devices. Only if the manufacturer chooses to include it. None 6. Which of the following is a key characteristic of the Basic UDI-DI? It is unique to each individual device. It is assigned by the authorised representative. It is used to link devices with the same intended purpose, risk class, and essential design and manufacturing characteristics. It changes with every production batch. None 7. If a manufacturer makes a minor change to a device's software that does not affect its intended use or performance, does the Basic UDI-DI need to be changed? Yes, any software change requires a new Basic UDI-DI. No, the Basic UDI-DI remains the same. It depends on the risk class of the device. It depends on whether the software change is documented. None 8. Which of the following is NOT a component of the UDI? The UDI-DI. The UDI-PI. The MDR certificate number. The production batch number. None 9. The Basic UDI-DI is used in which of the following documents? The device's instructions for use. The device's clinical evaluation report. The device's Declaration of Conformity. The patient's implant card. None 10. What is the role of an issuing agency in the context of Basic UDI-DI? To manufacture the physical UDI labels. To assign Basic UDI-DIs to medical devices. To regulate the use of UDIs in healthcare facilities. To maintain the EUDAMED database. None 11. What is the primary role of the Basic UDI-DI within the EUDAMED database? To identify individual devices for tracking within the supply chain. To serve as the key identifier for device registration and linking related device information. To provide detailed technical specifications for each device model. To store post-market surveillance data for individual devices. None 12. Which of the following statements is true regarding the relationship between Basic UDI-DI and EUDAMED? The Basic UDI-DI is only used for post-market surveillance reporting in EUDAMED. The Basic UDI-DI is submitted to EUDAMED by the Notified Body. The Basic UDI-DI is a mandatory data element for device registration in EUDAMED when all the modules are active. The Basic UDI-DI is not relevant for devices placed on the market before the MDR date of application. None 13. Why does the assignment of the Basic UDI-DI by the manufacturer have an impact on the Notified Body’s work? Has not impact Impact on the TD sampling (as per MDCG 2019-13) Impact on the SSCP assessment / validation Impact on the PSUR assessments 14. Is it possible that a device and a procedure pack (according Art. 22(3)) have the same Basic UDI-DI? Yes No None 15. Even outside of EUDAMED, can a Notified Body validate a given Basic UDI-DI? Yes No None 16. Specifically for contact lenses, what of the following is true: Contact lenses do not need a Basic UDI-DI Contact lenses do need a Basic UDI-DI and a Master UDI-DI None 17. If a manufacturer specified many product models (UDI-DI) under on Basic UDI-DI, can a notified body request the manufacturer to split them into separate Basic UDI-DIs? Yes, to reduce complexity of technical documentation assessment for the device No, it is the manufacturer’s responsibility Yes, if the product models have different essential design, manufacturing characteristics, risk class or intended purpose. None 18. When the notified body can assess correctness of product grouping in Basic UDI-DI? Application review QMS audit Technical documentation assessment 19. Does grouping of products in Basic UDI-DI have impact on sampling of technical documentation assessment? No, the sampling is based on Basic UDI-DI level Yes, all UDI-DIs are subject for the sampling May have, even though the sampling is based on Basic UDI-DI level, the complexity of the device (number of UDI-DIs) may be a considered by a notified body as a criteria for prioritizing the devices in the sampling None 20. Which statement is correct? If a device include different variant, models or sizes, the assessment of the technical documentation should cover at least the most hazardous variant of the device (UDI-DI). If a device include different variant, models or sizes, the assessment of the technical documentation should also include the assessment of how the differences among the models/variants/sizes have been addressed in the technical documentation and whether all of them are in line with the relevant requirements. None 21. Does EU technical documentation assessment certificate include an information about product grouped in Basic UDI-DI? No, the products covered by the EU technical documentation assessment certificate are identified by Basic UDI-DI Yes, the EU technical documentation assessment certificate should include among others Basic UDI-DI, name, model and type of the device or devices covered. None Time's up pascaleperspectives2025-02-20T14:19:53+01:00
