Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer currently undergoing EU MDR TF Review for a Class IIa device. My understanding is that we are in Independent Review at this time and they have just finished Clinical Review.

I was sent an email saying that the NB was changing our MDA code from the one we applied with to a new MDA code that we feel is only sort-of relevant/too specific to a function that is not the overall intended functionality of the device. I questioned this; they performed an internal review and reconfirmed their intent to change our MDA code.

My question is -- is there any risk in accepting their updated MDA Code? Overall, it seems like our TF review is progressing, and nothing in the MDCG guidance makes it seem like there's any affect to us -- it seems more like guidance for the NBs rather than manufacturers so that they have the appropriate resources.

Thanks in advance! I appreciate your inputs.

Hello Anon,

This is an interesting one which you might probably be right, they are changing the MDA Code to align with their internal resources.  If this is or is not the case, the impact of changing the MDA Code should not affect review of your technical documentation or quality system.  This is an identification for the Notified Bodies as part of their process and why needed on the application to ensure they have the resources in that code to complete the conformity assessment.  Though personally, I would want more transparency for the decision or reason for the change, just not an 'internal review.'  You are a paying customer and should be untitled to understand why they are changing an item such as the MDA Code.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Dec-2022 10:18
From: Anonymous Member
Subject: EU MDR MDA Codes and their implications?

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer currently undergoing EU MDR TF Review for a Class IIa device. My understanding is that we are in Independent Review at this time and they have just finished Clinical Review.

I was sent an email saying that the NB was changing our MDA code from the one we applied with to a new MDA code that we feel is only sort-of relevant/too specific to a function that is not the overall intended functionality of the device. I questioned this; they performed an internal review and reconfirmed their intent to change our MDA code.

My question is -- is there any risk in accepting their updated MDA Code? Overall, it seems like our TF review is progressing, and nothing in the MDCG guidance makes it seem like there's any affect to us -- it seems more like guidance for the NBs rather than manufacturers so that they have the appropriate resources.

Thanks in advance! I appreciate your inputs.

As Richard stated, they are most likely suggesting the change based on their internal resources. The NB needs to be qualified to review the device code and perhaps they either have more qualified resources in one code than the original , or maybe they are not qualified at all for your original code. At the end of the day it should only matter if you want to switch NB's down the road and cannot find another NB qualified for the new device code, or at least that would be my best guess.

------------------------------
Steven Kachelmeyer RAC
VP Regulatory and Quality Affairs
Windermere FL
United States
------------------------------

Original Message:
Sent: 09-Dec-2022 10:18
From: Anonymous Member
Subject: EU MDR MDA Codes and their implications?

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer currently undergoing EU MDR TF Review for a Class IIa device. My understanding is that we are in Independent Review at this time and they have just finished Clinical Review.

I was sent an email saying that the NB was changing our MDA code from the one we applied with to a new MDA code that we feel is only sort-of relevant/too specific to a function that is not the overall intended functionality of the device. I questioned this; they performed an internal review and reconfirmed their intent to change our MDA code.

My question is -- is there any risk in accepting their updated MDA Code? Overall, it seems like our TF review is progressing, and nothing in the MDCG guidance makes it seem like there's any affect to us -- it seems more like guidance for the NBs rather than manufacturers so that they have the appropriate resources.

Thanks in advance! I appreciate your inputs.

This message was posted by a user wishing to remain anonymous

Thanks so much for this insight. I appreciate your post!
Original Message:
Sent: 10-Dec-2022 15:26
From: Steven Kachelmeyer
Subject: EU MDR MDA Codes and their implications?

As Richard stated, they are most likely suggesting the change based on their internal resources. The NB needs to be qualified to review the device code and perhaps they either have more qualified resources in one code than the original , or maybe they are not qualified at all for your original code. At the end of the day it should only matter if you want to switch NB's down the road and cannot find another NB qualified for the new device code, or at least that would be my best guess.

------------------------------
Steven Kachelmeyer RAC
VP Regulatory and Quality Affairs
Windermere FL
United States

Original Message:
Sent: 09-Dec-2022 10:18
From: Anonymous Member
Subject: EU MDR MDA Codes and their implications?

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer currently undergoing EU MDR TF Review for a Class IIa device. My understanding is that we are in Independent Review at this time and they have just finished Clinical Review.

I was sent an email saying that the NB was changing our MDA code from the one we applied with to a new MDA code that we feel is only sort-of relevant/too specific to a function that is not the overall intended functionality of the device. I questioned this; they performed an internal review and reconfirmed their intent to change our MDA code.

My question is -- is there any risk in accepting their updated MDA Code? Overall, it seems like our TF review is progressing, and nothing in the MDCG guidance makes it seem like there's any affect to us -- it seems more like guidance for the NBs rather than manufacturers so that they have the appropriate resources.

Thanks in advance! I appreciate your inputs.