Identification & Traceability - ISO13485:2003 - Clause 7.5.3.2 - Distributors

GStough

Leader
Super Moderator
I believe I understand what this requirement is saying, but could someone please confirm whether my grasp of this "shall" is correct?

The shall: "...The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection.."

My understanding of it: In our company, we have many distributors who sell our product to end users who could be located anywhere in the world. According to this "shall", we must require our distributors to maintain records of some kind that would allow us to trace our product to the end user, and we should be able to inspect those records.

Please correct me if this is not the correct interpretation of this "shall"....

Thanks so much for your help! :)
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: 13485:2003 - 7.5.3 Identification & Traceability (7.5.3.2)

I believe I understand what this requirement is saying, but could someone please confirm whether my grasp of this "shall" is correct?

The shall: "...The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection.."

My understanding of it: In our company, we have many distributors who sell our product to end users who could be located anywhere in the world. According to this "shall", we must require our distributors to maintain records of some kind that would allow us to trace our product to the end user, and we should be able to inspect those records.

Please correct me if this is not the correct interpretation of this "shall"....

Thanks so much for your help! :)

Gidget,

I would agree with your interpretation regarding this clause. :agree1: but my expertise might be slightly short on 13485:2003. But even with that, I would still agree with your interpretation.
 

DannyK

Trusted Information Resource
The requirement is from clause 7.5.3.2.2 and applies to active implantable and implantable medical devices where there it is essential to have traceability.

Obviously if you were distributing digital thermometers you could not impose this requirement to your distributors
 
G

Gert Sorensen

I believe I understand what this requirement is saying, but could someone please confirm whether my grasp of this "shall" is correct?

The shall: "...The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection.."

My understanding of it: In our company, we have many distributors who sell our product to end users who could be located anywhere in the world. According to this "shall", we must require our distributors to maintain records of some kind that would allow us to trace our product to the end user, and we should be able to inspect those records.

Please correct me if this is not the correct interpretation of this "shall"....

Thanks so much for your help! :)

I believe that you are pretty much on the mark with your interpretation. The issue is more about defining the end user. Normally, the end user would be a hospital, nursing home, pharmacist or the like. So, you distributors need to keep records showing who received items from a specific lot (there may be a more narrow definition for things like pacemakers etc.), but for most medical devices this is the level you would require.
 
R

Rob Udo

It may not only be a ISO13485 issue, but it is a Medical Device Directive requirement as well. The MDD requires in Annex II, E.R. 3.1 that the manufacturer must be able to recall products that have a malfunction as described in E.R. 3.1 i). If you make use of a distributor, you need to be able to locate all possible users in order to instruct them what to do with your products.

The most straightforward way is to have your distributors keep track of which lot numbers were shipped to their customers.

Regards,
Rob.
 
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