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Implant Card - Article 18.1(a) and MDCG 2019-8 clarification

#1
Hello, I am working on developing implant cards to meet the upcoming MDR requirements. Inclusion of the "Device Model" and "UDI", as stated in the MDR, seems pretty clear. To my company, Device Model just means the part number and the MDR defines UDI as DI + PI. My notified body is BSI and my interpretation was confirmed via a 1/24/2019 webinar (google it, easy to find). However, the Medical Device Coordination Group came out with their guidance a few months later - MDCG 2019-8, and these seem to conflict. MDCG interprets Device Model as a type of device (therefore requiring translations) and UDI as UDI-DI. The BSI webinar even uses the UDI-DI as an example of a non compliant implant card. As we all know, MDCG is not binding but it is typically a pretty good resource. Thoughts on which way we should go?

Thanks,

Paul
 
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yodon

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#4
Ugh.. that's ridiculous - it's not consulting to ask if a particular approach would be acceptable. They ultimately have to approve.
 
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