A
How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?
Anonymous
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1 comment
about 2 hours ago
I am preparing the General Safety and Performance Requirements (GSPR) for a software as a medical device (SaMD) intended for in vitro diagnostic (IVD) use and have a question regarding IVDR Annex I, A
Accepted answer
You're right that not all aspects of Article 9.1(a) make sense for SaMD-IVDs, but it's generally not correct to mark the entire requirement as 'not ap