How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?
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, Article 9.1(a).
This section includes requirements such as analytical sensitivity, trueness, precision, accuracy, limits of detection and quantitation, etc. For software, it makes sense that analytical sensitivity may not apply, but others like precision or accuracy could be relevant.
I have seen some cases where this entire requirement is marked as 'not applicable' for software, with the rationale that the software only performs calculations. However, I am not sure this is correct. Should this requirement always be marked as applicable for SaMD-IVDs, with specific notes on what is relevant and how each aspect is addressed? Or is it appropriate to mark the whole requirement as not applicable with justification?
1 comment
A
Anonymous
about 4 hours ago
Could you provide more details about your specific device or use case?
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