Experience navigating significant change notifications under MDR/IVDR for SaMD

Question

Are you working in regulatory affairs or quality assurance at a software as a medical device (SaMD) company with a device certified under MDR or IVDR?
I am interested in your experiences with navigating a "significant change" with your Notified Body (NB), specifically:
• What kind of significant change did you implement?
• How was your overall experience with your Notified Body during this process?
• Which documents did you need to update or submit?
• What was the timeline for the review, from submission to approval?
• Could you share approximate costs associated with the review?

Any tips or lessons learned would also be extremely valuable. Thank you in advance for your input!

Dr. Oliver Eidel · Accepted Answer

We recently went through a significant change notification for an MDR Class IIb SaMD. Our internal procedure is to notify changes only when significant or if we're unsure about significance, following the MDCG guidance. This approach was accepted by our NB (BSI).
Process-wise, we submitted the change using their notification form, which asks for a description and impact assessment. BSI did an initial review to decide if more in-depth review was needed. We were told timelines and costs would be based on that assessment, but you can sometimes find indicative fees on your NB's website. In our case, a change to the operating threshold of an image analysis algorithm was reviewed within three days, and BSI informed us it would be checked at the next surveillance audit—so no further review was required at that point. All we submitted was the completed NB notification form for this initial assessment.
Timelines will vary based on your NB's availability and the nature of the change, but expect anywhere from a few days for minor changes (with no immediate follow-up) to several months for more complex ones. It's helpful to clarify your NB's process and expectations up front.

Answer

It really depends on your conformity assessment route and your device's risk class. For example, class IIa/IIb (non-implant), class IIb (implant), and class III have vastly different requirements. It determines whether you need to report substantial changes to the device range or just significant changes affecting performance. Make sure to check the MDCG guidance and your NB contract for specific definitions and requirements.
Also, we've found that Notified Bodies sometimes over-ask for documentation, so it's worth pushing back if requests seem excessive. If the change doesn't impact the device range for something like class IIa, sometimes a design change notification isn't even required.
For more detail, you can refer to MDCG guidance and your NB's published procedures or reach out to your NB directly for clarification.

Experience navigating significant change notifications under MDR/IVDR for SaMD

2 Answers

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