Medical Device Nomenclature - GMDN and ISO15225 - When should it be applied?

K

Kary13

#1
Hello all,

I find lots of questioning as to "how such a device should be classified". HOwever, those questions always seems to come after an organization specifically asked for a GMDN number. I want to take a step back and ask this question:

Should all manufacturer comply with ISO 15225? If such, should it be used "only" in a catalog way (meaning to identify the list/types of products the company produces)? Also, some comments talk about a registration of that number...

As you can probably see, I am lost in all that and would really appreciate a hand on the basics of all this... :bonk:

Thanks!
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Re: GMDN / ISO15225: When should it be applied?

Old post, but is anyone familiar with the ISO 15225 standard? If you can help, my Thanks in advance!
 
M

MIREGMGR

#3
Product classifications indicate risk level. Common systems include EC MDD's I, IIa, IIb, III; US FDA's I, II, III; and Health Canada's I, II, III, IV.

Product codes indicate product functionality or intended use. Common systems include GMDN, UMDN and the US FDA three-letter system.

Product classification is essential. It's the foundation for most product regulatory actions.

Product coding is required but less essential. In most regulatory systems, the product classification determines the regulatory requirements that apply to a product.

ISO 15225 (which by the way has been revised since the original posting in this thread) primarily is intended for use by persons who are responsible for managing large amounts of medical device product information. It specifies a standard format for a product information database, including the GMDN number as a key product-code descriptor.

The company for which I work doesn't make any use of ISO 15225, though of course we do list GMDN/UMDN codes on our product-list declarations to our European Authorized Representative.
 
#4
Hello all,

I find lots of questioning as to "how such a device should be classified". HOwever, those questions always seems to come after an organization specifically asked for a GMDN number. I want to take a step back and ask this question:

Should all manufacturer comply with ISO 15225? If such, should it be used "only" in a catalog way (meaning to identify the list/types of products the company produces)? Also, some comments talk about a registration of that number...

As you can probably see, I am lost in all that and would really appreciate a hand on the basics of all this... :bonk:

Thanks!
No, 15225 is a QMS for medical device nomenclature structures.
 
Y

yolanda1

#5
I also confused about this issue, as my customer notified body ask for Technical doc assessment for every products from our notified body , but as it is referenced in "Guidance on Notified Body‘s Tasks of Technical
Documentation Assessment on a Representative Basis" , only some sampling plan were perfomed for Class IIa and Class IIb , not for every products, so i am searching for the classification rules for"generic device groups", the relationship between "generic device groups" and GMDN code system.
 
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