Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Due to supply chain challenges, we need to utilize the tyvek pouch for variant B on variant A of the same product.  The pouch differs only in width; the two pouches have been tested with the product variants but are indicating separately on the BoM.

Do we need NB review and approval prior to implementing in EU?

Product is on market under MDD.

Frankly, there are probably too many variables to definitively answer based on the information you've provided thus far.  Those variables relate to things like the particular subject device type along with package/product integrity in relation to storage and transit, shelf life, sterile seal validation (if a sterile device), sterilization process validation (if a sterile device), manufacturability, etc.  So it will be important to, in such terms, better understand how the two pouches have been "tested" with the two device variants.  Ultimately, you need to work through the flowchart and supporting narratives in MDCG 2020-3, especially, but not necessarily limited to, the Main Chart and Charts B & E.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Jul-2022 09:58
From: Anonymous Member
Subject: MDR Article 120 Change

This message was posted by a user wishing to remain anonymous

Due to supply chain challenges, we need to utilize the tyvek pouch for variant B on variant A of the same product.  The pouch differs only in width; the two pouches have been tested with the product variants but are indicating separately on the BoM.

Do we need NB review and approval prior to implementing in EU?

Product is on market under MDD.

And you also need to understand any particularities that are unique to your Notified Body (NB) if any is involved.  Your NB contract will give you further insights on that.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Jul-2022 14:10
From: Kevin Randall
Subject: MDR Article 120 Change

Frankly, there are probably too many variables to definitively answer based on the information you've provided thus far.  Those variables relate to things like the particular subject device type along with package/product integrity in relation to storage and transit, shelf life, sterile seal validation (if a sterile device), sterilization process validation (if a sterile device), manufacturability, etc.  So it will be important to, in such terms, better understand how the two pouches have been "tested" with the two device variants.  Ultimately, you need to work through the flowchart and supporting narratives in MDCG 2020-3, especially, but not necessarily limited to, the Main Chart and Charts B & E.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Jul-2022 09:58
From: Anonymous Member
Subject: MDR Article 120 Change

This message was posted by a user wishing to remain anonymous

Due to supply chain challenges, we need to utilize the tyvek pouch for variant B on variant A of the same product.  The pouch differs only in width; the two pouches have been tested with the product variants but are indicating separately on the BoM.

Do we need NB review and approval prior to implementing in EU?

Product is on market under MDD.

Hello Anon,

Indeed there are a few factors which may need to be considered as a "significant change", but in essence you should use the criteria in MDCG 2020-3 as stated, the NBOG guidance on change, and any criteria your Notified Body has for notification of changes.  Notified Bodies typically have a list of what would be a significant change, what changes need to be reported, what changes might need to wait before implementing (needing approval), and how notification can be made.  In many cases, Notified Bodies have created more stringent and detailed change notification under EU MDR (including Article 120) so I would review that first.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 07-Jul-2022 14:12
From: Kevin Randall
Subject: MDR Article 120 Change

And you also need to understand any particularities that are unique to your Notified Body (NB) if any is involved.  Your NB contract will give you further insights on that.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Jul-2022 14:10
From: Kevin Randall
Subject: MDR Article 120 Change

Frankly, there are probably too many variables to definitively answer based on the information you've provided thus far.  Those variables relate to things like the particular subject device type along with package/product integrity in relation to storage and transit, shelf life, sterile seal validation (if a sterile device), sterilization process validation (if a sterile device), manufacturability, etc.  So it will be important to, in such terms, better understand how the two pouches have been "tested" with the two device variants.  Ultimately, you need to work through the flowchart and supporting narratives in MDCG 2020-3, especially, but not necessarily limited to, the Main Chart and Charts B & E.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Jul-2022 09:58
From: Anonymous Member
Subject: MDR Article 120 Change

This message was posted by a user wishing to remain anonymous

Due to supply chain challenges, we need to utilize the tyvek pouch for variant B on variant A of the same product.  The pouch differs only in width; the two pouches have been tested with the product variants but are indicating separately on the BoM.

Do we need NB review and approval prior to implementing in EU?

Product is on market under MDD.

For article 120, follow the MDCG guidance document to determine if the change is significant. If it is significant, you can't make the change under Article 120.

If it not significant, then read your contract with the NB to determine reportability. Depending on the NB it could be no notification, notification but not pre-approval, pre-approval, etc.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 06-Jul-2022 09:58
From: Anonymous Member
Subject: MDR Article 120 Change

This message was posted by a user wishing to remain anonymous

Due to supply chain challenges, we need to utilize the tyvek pouch for variant B on variant A of the same product.  The pouch differs only in width; the two pouches have been tested with the product variants but are indicating separately on the BoM.

Do we need NB review and approval prior to implementing in EU?

Product is on market under MDD.