PMS Training Welcome to your PMS Training Name Email 1. The periodic safety update report is required to be uploaded by manufacturers to EUDAMED for which classification of devices? Class I only Class III only Class III & Implantable devices Implantable devices only None 2. The notified body is required to upload its evaluation to EUDAMED for which classification of devices? Class I only Class III only Class III & Implantable devices Implantable devices only None 3. A manufacturer of a class IIa non-implantable device is required to produce a PSUR at least… Every Year Every Two years Every Three Years Every Five Years None 4. Which of the following datasets are not required to be included in the periodic safety update report? Complaints Vigilance CAPAs related to internal staffing issues CAPAs related to complaints None 5. Which of the following ongoing clinical activities should be included in the PSUR? Outputs of new risks identified from Literature searches PMCF Data Registry Data All of the above None 6. A manufacturer who holds a certificate under the directives but has not placed or put into service a medical device after the 26th of May, 2021 is still required to produce a PSUR. True False None 7. Notified bodies are required to upload their evaluation to EUDAMED for class III legacy devices that hold a directive certificate only. True False None 8. Which of the following post-market surveillance activities may trigger an update to the summary of safety and clinical performance (SSCP)? PMCF Data New risks identified from literature Registry data confirming performance is not as expected All of the above None 9. Which of the following activities shall be considered as input into PMS? Literature research regarding the own device Literature research regarding similar devices Literature research regarding state-of-the-art Literature research performed for a product development 10. PMS activity shall be performed by manufacturer of… only Class II.a, II.b and III. devices. only Class I devices. each devices. each devices with the exception of custom made devices. None 11. The post-market surveillance procedure is a part of the manufacturer’s QM system. is a rapidly changing procedure, at least a yearly revision will be required. shall be a general procedure of the manufacturer. shall be a product specific procedure. 12. The MDR requirements towards PMS activity declares the following: it shall be the same for each type of device. it shall be proportionate to the risk class it shall be appropriate for the type of device. it is a facultative activity, in case of devices where no PMCF study is required PMS is not required either. 13. The post-market surveillance plan is a general plan, covering all devices of the same manufacturer. is a device (device type) specific plan. in required only for Class II.a, II.b and III devices. shall also contain the methods to analyse complaint, but also the ones for data assessment. 14. MDR requires proactive data collection. Which of the following cannot be considered a proactive data collection? Complaint evaluation. Vigilance evaluation. Literature evaluation. Trend evaluation. 15. A Post Market surveillance system is mandatory for all Manufacturers under MDR Yes No None 16. A Post Market surveillance system Shall take into account relevant data on the quality, performance and safety of a device Shall be used to update the benefit-risk determination Shall be used to update the Technical Documentation All of the above None 17. How many sections does Annex II identifies for the Technical Documentation 5 6 7 8 None 18. One of the following is not part of the NB responsibilities: Evaluate PSUR + upload evaluation in EUDAMED Evaluate PMS report + upload evaluation in EUDAMED Audit PMS system None 19. Manufacturers are responsible for updating PMS plan PMS report/PSUR SSCP All of the above None Time's up pascaleperspectives2025-02-20T14:16:51+01:00
