Medical Device Recall Responsibilities between different Company Groups

[Aphel]

Hello Cove members,

Actually I am involved in discussion about finding the border line regarding "placing a device on the market" within a company group...

How do you solve the following situation:

Within a company group theres is one facility which is legal manufactuer (own quality system), one facility which is distributor (own quality system) and sells devices to customers, and one facility which does services and repairs (own quality system) after the devices are distributed.

When do you handle an action as recall?
If the manufacturer "calls back" devices (only) from the distribution center OR / AND when the manufacturer "calls back" devices from customers?

Thanks for your guesses!

Best regards,
Aphel

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Ronen E]

Hello Cove members,

Actually I am involved in discussion about finding the border line regarding "placing a device on the market" within a company group...

How do you solve the following situation:

Within a company group theres is one facility which is legal manufactuer (own quality system), one facility which is distributor (own quality system) and sells devices to customers, and one facility which does services and repairs (own quality system) after the devices are distributed.

When do you handle an action as recall?
If the manufacturer "calls back" devices (only) from the distribution center OR / AND when the manufacturer "calls back" devices from customers?

Thanks for your guesses!

Best regards,
Aphel

Sorry, but you didn't provide any details regarding the geographical locations of the entities, the commercial relationships between them (are devices sold between the locations) and/or the regulatory domain in question (EC, USA etc.).

 

[ganglai]

It is pretty much like the structure of our company, actual factory, legal manufacturer, distributor... Each of us has our own QS.

In regards to recall, it is the legal manufacturer or the sponsor in conjunction with the regulatory body of the regulatory domain to undertake a recall. A recall coordinator is appointed and leads the recall process.We have not had a recall. But the procedure is drawn up that way.