Is it appropriate to exclude ISO 13485 section 7.6 for SaMD under IVDR?

Question

Our product is a Software as a Medical Device (SaMD) that falls under the IVDR. It uses blood and genetic data as input to calculate disease risks for patients via machine learning. I am currently developing our quality manual and want to know if it is appropriate to exclude section 7.6 (Control of monitoring and measuring equipment) from our QMS. 
We do not develop or produce any physical or hardware medical devices, but rather use measured data as input to our calculations. However, one could argue that we are 'measuring' the risk of a disease. Should section 7.6 be excluded, or is there an appropriate way to address it for SaMD?

Dr. Oliver Eidel · Accepted Answer

For a client in a similar situation, we justified marking section 7.6 as not applicable by stating: 
We do not develop or produce physical or hardware medical devices, and this clause is excluded because we do not use any monitoring or measuring equipment during the design and development of our SaMD.

Answer

Rather than argue it is not applicable, sometimes you can reframe the clause to be useful for ensuring software quality. For example, if your software runs on a server, you may want to implement logging and monitoring to ensure it runs smoothly, doesn't crash, or overuse resources. However, the specific requirements in section 7.6 are often too focused on physical equipment to map directly to SaMD.

Answer

Agreeing with the previous points, it's usually best to exclude section 7.6 initially for SaMD. If an auditor later insists on covering server operations or similar aspects, you can address it then. Since server operations need to be managed anyway, you likely won't face extra requirements by waiting.

Is it appropriate to exclude ISO 13485 section 7.6 for SaMD under IVDR?

3 Answers

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