How important is using the "correct" GMDN?

JoshuaFroud

JoshuaFroud

Involved In Discussions
#1
#1
Good Morning All

About a year ago I took over as the Quality lead for a company making x-ray emitting medical devices. I have recently reviewed our GMDN account and technical file and found what I believe to be a potential discrepancy.

Without giving specifics (and getting in trouble for quoting the full details of the GMDN codes) there are two GMDN numbers that only differ by the final sentence "the main body of the unit is mounted on wheels" or "the main body of the unit is fixed" all other text for the code is identical. The rest of this is a number of sentences describing the device and its function/

Our technical file states that all of our systems fall under the second "the main body of the unit is fixed" GMDN number, however, one of our systems could be argued to have "the main body of the unit mounted on wheels".

What should I do and how would this impact country registrations where we have stated a GMDN number for the system that could potentially be incorrect?

I'm fairly new to the regulatory side of stuff and would appreciate some advice, thanks. Please let me know if I've not been clear or you would like any clarification.
 
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Mark Meer

Trusted Information Resource
#2
#2
I'll weigh in to hopefully provoke discussion - but unfortunately don't have a definitive answer.

My feeling is that it probably doesn't matter. In many cases (save going through a process of requesting new codes), the description you select is usually just "best fit". In previous threads I'd expressed my scepticism of the value of GMDN. Despite all the claims from the GMDN Agency of the codes facilitating data exchange and inventory management, I've yet to see where these codes are actually employed in practice (that adds value).

Can anyone with more knowledge of GMDN use kindly weigh in on the risks?
  1. What is the risk if your selected GMDN code is not the "best" fit (i.e. there is another code that could potentially describe more accurately)?
  2. What is the risk that a mistaken/misapplied code is ever identified (especially in cases where it's pretty close)?
  3. If the wrong code is used, what is the potential consequence?
I'd love to know. Please, someone sell me the value of GMDN codes. I'm sick of being so cynical about them! :p
 
JoshuaFroud

JoshuaFroud

Involved In Discussions
#3
#3
Thank you. It does not seem like an overly popular topic or something that people want to weight in on. Your comment of it not mattering too much, is pretty much where I had got to. As I have only recently been exposed to the joys of GMDN, I did not want to make that assumption without farming the question out to the wonderful people here.

I would be really interested to see what others opinions on your questions are. Hopefully, someone will feel compelled?!
 
somashekar

somashekar

Staff member
Super Moderator
#4
#4
JoshuaFroud said:
Good Morning All

About a year ago I took over as the Quality lead for a company making x-ray emitting medical devices. I have recently reviewed our GMDN account and technical file and found what I believe to be a potential discrepancy.

Without giving specifics (and getting in trouble for quoting the full details of the GMDN codes) there are two GMDN numbers that only differ by the final sentence "the main body of the unit is mounted on wheels" or "the main body of the unit is fixed" all other text for the code is identical. The rest of this is a number of sentences describing the device and its function/

Our technical file states that all of our systems fall under the second "the main body of the unit is fixed" GMDN number, however, one of our systems could be argued to have "the main body of the unit mounted on wheels".

What should I do and how would this impact country registrations where we have stated a GMDN number for the system that could potentially be incorrect?

I'm fairly new to the regulatory side of stuff and would appreciate some advice, thanks. Please let me know if I've not been clear or you would like any clarification.
Click to expand...
FAQ - GMDN Agency

What if I choose the wrong GMDN Code?
If the User wishes to change the GMDN Code selected for a particular product, it is recommended that the User discusses this with their Regulator or Conformity Assessment Body. Please contact us if you have any concerns. If users no longer want us to monitor a Term in the their 'My Terms' list, this can be moved to their 'My Archive' list.
 
moounir

moounir

Involved In Discussions
#5
#5
Thanks Somashekar for the FAQ from GMDN Agency.

Same as for Mark, I don't think this has a big impact. But lets discuss it.

Usually GMDN are used by Notified Bodies when they need to audit us. This is helpful for them to choose the right auditor with the right knowledge of the product.

This is also used for the registration and see to which category this products belong to.

I would say that what you describe is really a minor discrepency as the product is the same and the difference is between fix and mobile.

I would recommand to update that on your files and inform the Notified Body. But don't forget to include that on your QMS (Open a CAPA, NC or just information on the Management Review).

The auditor will check if there is an impact on the risk for the product. So a quick risk assessment should be done saying that there is no risk identified.

I know this can look a lot but it's only 1 letter, 1 announcement on your quality system and the information to the Notified Body.

Why?

Because it depends on your Notified Body and Auditor. If they discover it, they can raise an observation because your product identification is misleading, or they can say that your QMS was not used correctly to catch the issue and solve it or...

Auditors are human, so it can be nothing on the best case or at the extreme it can be a proof that your system is not working. I know stupid but I've met some auditors that were a bit too picky on anything. So I prefer you be on the safe side by performing a preventive action.

I hope this helped.
 
M

med_cert

Involved In Discussions
#6
#6
Some regulatory agencies require only one GMDN code. We are not able do define only one code for our product as there are at least three GMDN codes that alltogether cover intended use of our device...
Should we coose the GMDN code that covers the "main" intended use, should we insist on three GMDN codes,....?? Its really confusing... GMDN agency does not have solution, however they don't want to change/modify their GMDN terms.
 
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