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Migrating from whole product CE marking to modular approach

#1
Hello,

I work for a company which creates software that is very similar to the examples given in MDCG 2019-11 - Modules. The application consists out of many modules, from which only some have a medical purpose and qualify as a SaMD.

At present the whole solution is CE marked as a Class I device and we would like to migrate towards a scenario where only the relevant modules bear CE marking.

How would we best approach this? Can we update our existing notification and more clearly delineate and define what falls in scope or should we cancel our current CE marking and notify each of the modules as separate devices?

Any insight is greatly appreciated!

KR,
Arne
 
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yodon

Staff member
Super Moderator
#2
Would these modules, in and of themselves, be considered "medical devices" (SaMD)? They are truly stand-alone?
 
#3
Hi yodon,

First off my apologies for the late reply. Some urgent matters came up.

The modules are meant to calculate new values (provide information) based upon values which are either entered by health care workers or communicated by other systems. These calculated values are either used as input for treatment parameters or to monitor treatment efficiency.

The idea would be to isolate the software libraries performing these calculations as services. This allows for a clear boundary and makes them truly stand-alone. Theoretically they could even be installed on a completely separate server.

The services would define a clear contract towards other software components, i.e. defining the possible inputs and outputs that can be expected.

Hopes this clarifies a bit further.

KR
 

yodon

Staff member
Super Moderator
#4
No worries, no expiration dates. :)

What you describe doesn't sound like SaMD but just some library functionality that multiple (?) applications could use? What "medical purpose" does your software perform?

I'll admit that the IMDRF Key Definitions for SaMD does say that SaMD "may be used in combination (e.g., as a module) with other products including medical devices" but I still think it, on its own, has to have its own medical (intended) purpose. If they're just providing calculations, I don't see that as an intended medical purpose.
 
#5
Thanks for your answer.

The intention would indeed be to isolate the calculations as libraries which could potentially be used by multiple applications.

Can you please elaborate why you do not consider these libraries not to have a intended medical purpose? The resulting value will be used as a treatment setting (e.g. a parameter entered on another device). I considered that to meet the 'intended to be used for treatment of a disease'. There is no other use for these values being calculated unless for either monitoring or treatment of disease.
 

yodon

Staff member
Super Moderator
#6
Can you please elaborate why you do not consider these libraries not to have a intended medical purpose?
To have an intended medical purpose, you have to make a claim of what it does. Then you have to demonstrate that you meet those claims. Providing input is not an intended medical purpose, IMO. Your device is not monitoring or treating. Further, your software is not stand-alone if it only provides an input.

That's just my *opinion.* I would certainly suggest you consult with a regulatory expert.
 
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