Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company. 

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)? 

Thanks!

Hello,

From my perspective unless you have medical devices that are changing frequently or new iterations coming out, there is probably not any specific reason to keep a membership.  The GMDN numbers once established do not (should not) change that much only some products may get more refined.  A main reason for membership is when you have need to look up the database for numbers or you need a new number because of a device that does not have an existing GMDN.

There was undercurrent that the GMDN database would be publicly available which unfortunately has not happened yet, much to my dismay.  I struggle keeping polite words in public forums when regulators position requirements within their regulations, yet require companies to pay for those additional services.  The fact that FDA UDI, EU registration, and now even Health Canada require the use of GMDN, it boggles my mind that the database lookup is still not publicly available.  I have sent numerous emails to FDA pointing out this fact that this is not least burdensome approach.

Sorry for the rant !  But to answer your question, spending that 500 - 1000 Euro every year if your products are not changing that much is not worth it.  Even many regulators do not have access to GMDN database, so you most likely would not get challenged - difficulty arises when these databases all get connected and entering your UDI information gives an error because the GMDN number changed or was removed.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Sep-2018 11:56
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company.

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)?

Thanks!

I agree that once you have identified your GMDN codes, you really don't need to maintain the membership. If the need for another GMDN search is required, you can reach out to a consultant with a membership who can conduct the look-up for you and provide the code and definition. This is one of the services we provide at Qualitas Professional Services.

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Lena Cordie
Victoria MN
United States
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Original Message:
Sent: 11-Sep-2018 11:56
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company.

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)?

Thanks!

​I agree, its not worth the subscription fee.  Your GMDN codes are not likely to change.  Besides, Article 26 of the new MDR says that EUDAMED is going to offer the GMDN codes for free.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 11-Sep-2018 11:56
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company.

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)?

Thanks!

This message was posted by a user wishing to remain anonymous

Original poster here - thanks to all for your responses! I share your frustration that these codes are required by regulators and yet not freely available. Part of the reason we've been reluctant to renew is because we too are hoping this will be fixed soon, per the new MDR requirements. It sounds like we are on the right page with not renewing, and it's nice to have the reinforcement that we're doing the right thing!
Original Message:
Sent: 12-Sep-2018 11:12
From: Al Van Houdt
Subject: GMDN membership

​I agree, its not worth the subscription fee.  Your GMDN codes are not likely to change.  Besides, Article 26 of the new MDR says that EUDAMED is going to offer the GMDN codes for free.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 11-Sep-2018 11:56
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company.

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)?

Thanks!

This message was posted by a user wishing to remain anonymous

​While I would agree with the consensus that having a GMDN membership is not necessary if your product line is static, this agreement is in theory only.  In reality, we have found that many countries do not agree on the assigned GMDN codes and as a result we are forced to maintain separate GMDN codes for different countries (not so Global, after all).  Another issue that we are having is the PIM will resubmit our data periodically to the FDA, and if the GMDN was obsoleted after the initial submission, the FDA will require us to update our GMDN codes more often than we had anticipated.

Has anyone else run into similar problems with the GMDN?  How are you able to maintain GMDN codes for multiple countries?
Original Message:
Sent: 12-Sep-2018 14:23
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Original poster here - thanks to all for your responses! I share your frustration that these codes are required by regulators and yet not freely available. Part of the reason we've been reluctant to renew is because we too are hoping this will be fixed soon, per the new MDR requirements. It sounds like we are on the right page with not renewing, and it's nice to have the reinforcement that we're doing the right thing!
Original Message:
Sent: 12-Sep-2018 11:12
From: Al Van Houdt
Subject: GMDN membership

​I agree, its not worth the subscription fee.  Your GMDN codes are not likely to change.  Besides, Article 26 of the new MDR says that EUDAMED is going to offer the GMDN codes for free.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 11-Sep-2018 11:56
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company.

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)?

Thanks!

I recommend you exercise caution in thinking that the EU will offer GMDN for free. For the MDR, here are some considerations.

 

Article 26 says, "To facilitate the functioning of the European database on medical devices ('Eudamed') as referred to in Article 33, the Commission shall ensure that an internationally recognized medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavor to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable."

 

It doesn't say the system will be GMDN.

 

MDCG 2018-2 says, "[The] nomenclature shall be internationally recognized at the time of the date of application of the Regulations. In this context, global harmonization principles and orientations followed and adopted by the International Medical Device Regulators Forum (IMDRF) and the World Health Organization, are taken into particular account."

 

IMDRF could easily develop a system that is not the GMDN system. IMDRF is, for example, developing a system for coding adverse events. The FDA is adopting it, the EU will probably adopt it, and it will probably mean that the current ISO standards will be obsolete.

 

I note, for example, that ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure is now withdrawn and not replaced. That suggests the ISO/TC 210 is working on the issue.

 

It would be nice to hear from somebody on ISO/TC 210 about this issue.

 

 

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Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 12-Sep-2018 11:12
From: Al Van Houdt
Subject: GMDN membership

​I agree, its not worth the subscription fee.  Your GMDN codes are not likely to change.  Besides, Article 26 of the new MDR says that EUDAMED is going to offer the GMDN codes for free.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 11-Sep-2018 11:56
From: Anonymous Member
Subject: GMDN membership

This message was posted by a user wishing to remain anonymous

Hello colleagues!

I have a question about GMDN membership. We have always maintained a GMDN membership, but as we have only a few products and already know the codes for them, I question whether it's necessary to maintain this membership every year. The only value I can see is that we would be notified if any of our products' terms change, which is helpful. But I'm not sure it warrants the annual cost of membership for a small company.

Can anyone comment on how important it is to maintain GMDN membership (as opposed to just letting it lapse and then re-joining when needed)?

Thanks!