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Manufacturing plants relocation - Medical Device

#1
Good afternoon all,
I would like to ask you the following issue we are dealing with.

The situation is the following: There is a company developing a new medical device which is being manufactured by a subcontractor in a certified facility. Several tests have been carried out with these devices in order to eventually submit the documentation to a Notified Body. But, before that happens, the subcontractor manufacturing the devices changes its manufacturing plant to a different location, although the manufacturing procedures are more or less the same. Shall the company re-do all the tests that were carried out with the devices from the old plant? What would the company need to demonstrate in order for those studies be considered acceptable by a Notified Body?

pd: Notified Body: they evaluate MD in Europe

Thank you very much in advance for all your support. Appreciate it!
J.
 
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#3
Thanks indubioush for your help!

At the old location it was done the whole manufacture of the product. Now they change the manufacturing site and, thus, some procedures will need to be re-validated or validated but that is not what we are worried about. We are worried about if we can use nonclinical and clinical tests carried out with the products manufactured at the old plant or if we need to conduct these studies again. In other words, at which level do we need to demonstrate that the products are the same when manufactured at the old facility and the new one? Is it enough if both comply with the specifications?

thanks again in advance, J
 

indubioush

Quite Involved in Discussions
#4
You should have a documented "move plan" in which you describe your rationale and justification for redoing or not redoing certain tests. Only you can determine what needs to be redone. Don't overthink it. If a manufacturing process is happening the exact same way with the same equipment, material, people, process, etc., that is justification as to why a process output at the new location is the same as the old location.
 

indubioush

Quite Involved in Discussions
#5
Note that you will have to perform equipment qualifications if movement of the equipment could cause the equipment to operate differently.
 
#6
Note that you will have to perform equipment qualifications if movement of the equipment could cause the equipment to operate differently.
Thank you very much indubioush again. Your answers really help!

I would like to know what you think about the following: probably there will be some changes on the processes in the machinery when moving to the new plant. However, most of them will be related to un upgrade to a newer version of the machine or upgraded processes. DO you think that this jeopardise all the tests carried out in the other plant¿ which tests or justifications would you recommend us to provide to the NB?

Thanks again,
J
 

indubioush

Quite Involved in Discussions
#7
Sorry, but that is not enough information to help. Only you can determine what additional testing needs to be done. You need to assess all the changes to see how they might affect your product. If you need additional assistance, I suggest you hire a consultant. The fact that you seem lost indicates your organization probably has a lack of knowledge in other areas as well.
 

levatorsuperioris

Involved In Discussions
#8
make it easy,

I assume it's class 3 EU _. under MDD this is a product change. Product change moving a manufacturing facility alone will likely trigger an assessment audit. So yes you need to notify the NB and you are out of time to do so if the MFG facility is listed under the Annex 2 (with 4) product cert. If it's not listed, you have a chance but the rules of what a significant change change for the MDD under the MDR (NBOG issued a document).

If its not class 3 EU (no special rules sterile etc, new GMDN, MD code) then you didn't have to notify the NB in the first place. "New Model"
 
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