Manual on Borderline Classification Version 2 - December 2022
By Mitch on Friday, 16 December 2022, 13:50 - Regulations - Permalink
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.
Medical Calculators
Have a look at section 1.1.9.2 Medical Calculators and make your own judgment.
Mine is that class IIa for such tool informing on clinical management is overkill.
Deadly Rule 11, once again.
Tremble, you poor excel sheets and web forms!
Comments
Definitely an overkill. More clueless people writing regulations.
Also, isn't this in conflict with the example from MDCG 2021-24 for "MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm" on page 44?
I don’t think it is contradictory. Their argument is that conception is neither diagnosis nor treatment. Thus not doomed by the first paragraph of rule 11.