One of the companies I’m supporting has a configurable product that can currently monitor symptom worsening for medical conditions. Their business model is to add other medical conditions to the platform as they are able to validate the platform’s effectiveness in identifying symptom worsening of diseases in different patient populations. A very solid business model.
Their questions are, naturally, whether each new configuration will need to be reviewed as a separate device with its own conformity assessment (essentially a non-starter for a smaller company given how high costs for a new CA are)? Or are there easier, shorter, and less costly options?
Start by asking yourself, “will this change have an impact on the product’s new indication for use or instructions for use?” If the answer is yes, you are probably dealing with something more complicated than simply having NBs review updates to your technical documentation at the next annual audit. But we are still left wondering which of the other possible paths we might be able to take with this particular device. For a quick review of the options:
What’s frustrating here is that in both cases, the trigger is the same: a change that could affect the safety or performance of the device or the conditions prescribed for its use. Great, got that.
But what determines whether a NB will deem the change a supplement or a new device?
This is where there is no clear guidance. The NBs make the determination. That’s it.
I spoke with one representative of a Notified Body that specializes in SaMD, and when I asked about new disease-specific configuration of our device, he effectively said, “that’s your choice. You can either present the change as a substantial change or choose to add a new device to your certificate.” That seemed disingenuous and, according to the MDR, this is a choice that the NBs have to make, not manufacturers.
And, of course, the NBs have an interest in qualifying changes as new devices, as this designation (new UDI, etc.) comes with a justification for charging higher fees for ongoing reviews. For example, for the notified body i mentioned above, a new device would result in an 20,000 EUR increase in their annual costs.
I sadly do not have any clear cut answers on how NBs decide, except to say that they decide. I can say this: be careful. Read guidance documents that NBs use so you can have an engaged discussion with them on anticipated configurations you plan to make to your product. Shop around. Ask for something called a “Structured Dialogue” with the NB, which is something they are encouraged to do before you send in an application for a conformity assessment. During this Dialogue, you may get some clarity into their protocols and processes for deciding such matters. You can also read guidance from 2014 that NBs still apparently use to make decisions concerning substantial changes (see page 7 for a specific discussion concerning software).
Pro tip #1: Significant changes and substantial changes are different things. Significant changes are only used in the circumstance of transitioning products from MDD to the MDR. Do not confuse them.
Pro tip #2: you may come across this guidance document describing significant changes. It would seem highly useful (flow charts and all), but apparently NBs have found this guidance frustrating and prefer the 2014 guidance document instead. So don’t use this document thinking “significant change” and “substantial change” are interchangeable (see Pro tip #1).