MDR Class Ir deadline (Reusable surgical instruments)

Raisin picker

Involved In Discussions
#11
I'm not sure if there's something in the MDR that makes your life easier here. You have to define the amount of data you need to present to show that your device complies with the respective GSPR. Based on the age, abundance and risk profile, you can justify to use a lower amount of data than for, say, a hip implant. You will, of course, find no publications about current clinical trials comparing a scalpel with a pair of scissors. But there are a number of other data sources like textbooks, recommendations from medical societies and the like. You, of course, have a vast amount of PMS and PMCF data, since you are aware of this problem for 5 years now ;-)
And, you're not alone. I know about an initiative in the German Medical Valley, Tuttlingen. The local organizations Medical Mountain and BioPro BW are working to provide generic data (link is in German language) for their members on such basic devices. They seem to be willing to sell to people outside the region, I think. But although they cover a number of device types (e.g. mechanical surgical saws), scissors and scalpels seem not to be included.
 
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zeypzeyn

Starting to get Involved
#13
You could always run a clinical investigation.
Sure, but we have almost 15 thousand type of surgical instruments. I won't be feasable to run a clinical investigation.


I'm not sure if there's something in the MDR that makes your life easier here. You have to define the amount of data you need to present to show that your device complies with the respective GSPR. Based on the age, abundance and risk profile, you can justify to use a lower amount of data than for, say, a hip implant. You will, of course, find no publications about current clinical trials comparing a scalpel with a pair of scissors. But there are a number of other data sources like textbooks, recommendations from medical societies and the like. You, of course, have a vast amount of PMS and PMCF data, since you are aware of this problem for 5 years now ;-)
And, you're not alone. I know about an initiative in the German Medical Valley, Tuttlingen. The local organizations Medical Mountain and BioPro BW are working to provide generic data (link is in German language) for their members on such basic devices. They seem to be willing to sell to people outside the region, I think. But although they cover a number of device types (e.g. mechanical surgical saws), scissors and scalpels seem not to be included.
Yes, Our strongest suit would be PMS and PMCF data thanks to our properly working quality management system.
 

zeypzeyn

Starting to get Involved
#18
And you think you need to find published studies because? (Not a trick question) (Or at least not intentionally so)
Because we are told to do literature search by searching published studies of the equivalent device instead of running a clinical research of our own device. But all we can find studies in which the equalivent device is only mentioned.
 
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