How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?

Question

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?

Dr. Oliver Eidel · 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 applicable' just because the product is software. Instead, you should review each aspect (e.g., trueness, precision, accuracy, limits of detection) and indicate which ones make sense for your particular software. For example, precision and accuracy often do apply, while analytical sensitivity might not. 
It's good practice to mark the requirement as applicable, then add comments or notes in your GSPR explaining which parts are relevant and how you address them. For the aspects that aren't applicable, provide a brief justification. This approach shows that you've considered each requirement carefully and have a rationale for your conclusions.

Answer

Analytical performance/sensitivity doesn't really fit with SaMD-IVDs, but technical performance based on scientific validity, technical performance, and clinical performance is more relevant. You still want to describe how your software makes decisions at certain cutoffs, but this depends on what your software does. Overall, it's best to specify which parts of the requirement apply, and comment on how they're met or why they're not applicable.

Answer

I was wondering about this specific requirement too. Since so many performance indicators are listed, I think the requirement is always applicable, but you should specify in your notes which parts apply and how. For example, for cut-off values, you can explain how your software handles those. It's about being transparent on what is and isn't relevant for your product.

Answer

Some aspects like precision or accuracy make sense for at least some SaMD-IVDs, while others (like analytical sensitivity) may not. So I would also say the requirement is generally applicable, but you should add a comment specifying what exactly applies for your software.

How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?

4 Answers

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