PMS Training Welcome to your PMS Training First and Last Name Email Organisation 1. (EU) 2017/745 Annex III states the PSUR is included in the PMS Plan True False None 2. A PSUR is required for which of the following devices: Class IIa Class IIb Class III Custom made devices Annex XVI devices MDR devices no longer certified by continue to be on the market 3. PSURs for Class IIa and IIb non implantable devices do not need to be made available to Competent Authorities. True False None 4. When the PMS and vigilance module of EUDAMED is operational, PSURs and the PSUR Evaluation by the Notified Body will be available to the Public to view. True False None 5. What are the key principles for producing a PSUR? It is a summary document It must be able to be assessed independently from other documents It should contain all the raw data collected by the manufacturer to fulfil their PMS plan The format and content should align with MDCG 2022-21 guidance 6. 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 7. 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 8. 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. 9. 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. 10. 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. 11. MDR requires proactive data collection. Which of the following cannot be considered a proactive data collection? Complaint evaluation. Vigilance evaluation. Literature evaluation. Trend evaluation. 12. A Post Market surveillance system is mandatory for all Manufacturers under MDR Yes No None 13. 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 14. How many sections does Annex II identifies for the Technical Documentation 5 6 7 8 None 15. 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 16. Manufacturers are responsible for updating PMS plan PMS report/PSUR SSCP All of the above None Time's up pascaleperspectives2025-07-03T09:18:08+02:00
