Profile

Dear Thomas, you may find information within the Commission guidance: "Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure (Text with EEA relevance) (2020/C 259/02)" This document ...

Dear Stephanie, Thank you for sharing your insights. Your observations are quite intriguing. Just reading them makes my stomach turn. It seems like some individuals are out of touch. It is up to the community to address these issues. I remember an inspection I observed many years ago. The medical ...

Dear Stephanie, thank you for sharing the interpretations of some auditors/reviewers of NBs. I would hope that those are not the norm. The term benchmark is not being used in the MDR. Benchmarking to other medical devices in all aspects and expecting cutting edge technology thereof is not required. ...

Dear Stephanie, Thank you for bringing this up. It seems to me that there is an overinterpretation of the MDR. The definition of "SOTA" according to the Cambridge Dictionary is: "very modern and using the most recent ideas and methods." However, this is not what the MDR states. The MDR states: "taking ...

Dear All, I am unsure if I understand the question completely. A straightforward example of the transfer of ownership could be when someone purchases a product from a third country and takes it into their possession in the EU. They then sell it in the EU, making it available for the first time, which ...