Hi Michaela, Thank you for this informative video it was nicely detailed an provide many useful details. I am new to Usability Engineering and I have to perform Usabili Engineering report for product family which was commercialized after 2015, but has sufficient PMS data. The summative evaluation was not performed during design phase and it was already approved with MDD. Do you suggest that the Summative evaluation shd be performed in current date and provide evidence for safe design? Hoping to have your insight with presented scenario. Thank you
Hi Ashini, thank you for your question. In general, you do have two possibilities: 1. you can either integrate all the data from your PMS to your usability engineering file and try to show, why you are sure that the use of your device is free of unacceptable risk. Or 2. you can conduct a summative evaluation now, to make sure that you have fulfilled all regulatory requirements. Number 1 is a bit problematic and really depends on your notified body, because for devices commercialized after 2015 you are expected to have a summative evaluation. Before the MDR, this was seldomly checked. But now the focus is much more on usability and we got a lot of customers complaining about problems with the MDR approval because of missing summative evaluations. But nevertheless, we also had one or two successful customers that solely provided PMS data. If it works depends on the quality of your data, the class of your medical device and the mood of your notifies body :D Number 2 is probably the most correct and safest way. Wish you all the best! If you need assistance: Feel free to contact me on linkedin.
Thanks Michaela for this video its very interesting yet i am wondering if its possible to perform the sommative test on a final prototype ? or i am obliged to perform the sommative test on a finished product
Hi Michaela, thank you for the informative video! I would appreciate your advice regarding "summative evaluation" and "usability study". I see that both "summative evaluation" and "usability study" are mentioned in the standard, what are the differences between them? Thanks :) @michaelakauer-franz859
