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You want to go back to the beginning of your analysis in assessing the classification to make sure you have a good understanding of the classification or type of device. Without much information on the functionality and intended purpose or use of the software, it is difficult to answer certain questions. See this source for some guidance, especially if you are planning to submit under old versus new regs or if it is later classified instead under IVDR-new regs (or IVDD the old regs) versus MDD. This is why it is important to understand the nuances of the software as there are different considerations as a medical device versus IVD. With the new regs, the higher classification will be the one used.
AKRN - MDSW - MD or IVD software classification (akrnconsulting.com)However, once the NB has approved the device/software and performed its duties in assessing and assigning a CE Mark certificate, yes, you can say it is CE-Marked.
Original Message:
Sent: 10-Mar-2022 12:16
From: Anonymous Member
Subject: SaMD EU MDR Strategy
This message was posted by a user wishing to remain anonymous
Dear RAPS community,
Would appreciate any advice on this as we plan on our EU MDR submission strategy.
We have a mobile app currently with 2 modules/features classified as Class I under MDD. Our assessment is that it will be Class IIa under MDR (i.e. require NB approval). There are other modules/features within the app which has been assessed to not meet the Medical device definition, but they do have some sort of interactions within the medical device modules.
In our MDR submission strategy, we would like to submit to the notified body for the 2 modules as part of the MDR.
Here comes the confusion that our team find it difficult to grasp:
1. Upon MDR approval by the Notified Body, are we able to say that the App is CE-marked? Or would it only apply to the 2 modules?
2. We have an overall intended use for the mobile app, but we also classify individual intended uses for the features. In this case, since we have 2 modules which are considered medical devices, does that impact the overall intended use of the mobile app?
3. There may be an inclination from the team to split the 2 modules into 2 different STeD (for commercial purposes). If this is the case, what would be the impact from a regulatory perspective and from a review perspective from the notified body? [They share common documents like SRS, Software Verification etc.]
Sorry I know this may be confusing but would love to connect with software experts and discuss further on this.
Thank you so much!