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Degree of control of distributors - PMS

ShRam

Starting to get Involved
#1
Hi,

I was referring to the guidance by NB-Med while preparing PMS SOP. In the guidance, I came across "degree of control of distributors" and "different priorities/agendas of sales force" under Variables affecting the choice of achievements and information sources. I am not sure what does that means. Please clarify this.

Please find the link for the guidance here.


Thanks in advance.
 
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indubioush

Involved In Discussions
#2
For example, let's say all your products get distributed by one distributor. They do not record information about which user population uses the device. Therefore, you will not have this information to gain insight into how the device performance compares between populations. "Knowledge of performance in different user populations" cannot be an achievement of your PMS system.

Similarly, let's say you have a sales force that is so overworked that they often do not record information about proposed device improvements. This means that you probably will not expect to gain much information on device improvements through your post-market surveillance system, at least not through your sales force. You may try to obtain this information from other sources.
 
#3
Hi,

I was referring to the guidance by NB-Med while preparing PMS SOP. In the guidance, I came across "degree of control of distributors" and "different priorities/agendas of sales force" under Variables affecting the choice of achievements and information sources. I am not sure what does that means. Please clarify this.

Please find the link for the guidance here.


Thanks in advance.
Hi,

it means, that you need to be sure, that you, as manufacturer, are able to gain all information you need (based on your PMS plan) also from distribution chain. EU MDR will help us with this point, because all distributors will have obligation to inform manufacturers about all complaints and incidents.
 
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