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Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

yodon

Staff member
Super Moderator
#2
As always, thank you @Marcelo Antunes for posting. Seems it's getting much harder to keep up!

If I read this right, the MDCG mapped the MDR classification strategy (III, IIb, IIa) for ALL Medical Device SW into the classification framework creathed by the IMDRF for stand-alone software (SaMD). Did I get that right?

Apparently this didn't sit well with Antonio Bartolozzi, a professor of medical device software design at Trieste University in Italy. I just saw reference to an article indicating he feels the scheme does NOT align with the IMDRF approach. (Access to the article required registration to some organization and I chose not to sign up.) I do see that the IMDRF scheme uses categories I - IV but the MDCG scheme only maps 3 categories (excluding Class I software).

The teaser to the article also suggests that professor Bartolozzi also contends the MDCG paper has "errors and inconsistencies." I've read through (not a detailed examination) both docs but didn't notice anything glaring. Curious if anyone (else) has identified anything.
 
#3
I did notice some possible problems in the other thread in which we discussed rule 11, but I did not read enough of the document (I'm traveling abroad for the last two weeks and just came back to Brazil) to comment in more detail.
 
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