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Medical Device - Change manufacturing plant

R

RegulatoryUS_EU

Registered
#1
#1
Dear all,
I would like to ask you the following issue we are dealing with. Thank you very much in advance for all your support. Appreciate it!

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: the competent authority in charge of evaluating MD in Europe

J.
 
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Y

yodon

Staff member
Super Moderator
#2
#2
To be sure I understand: you did testing on devices to demonstrate they met requirements (you're not talking about production process validation, right)? Those tests demonstrate product requirements, nothing to do with the facility where they were made.

No, you shouldn't have to repeat those tests. You will need to ensure the new production site can make product which conforms to spec - so it's not just a matter of flipping the switch at the new production site.
 
R

RegulatoryUS_EU

Registered
#3
#3
Thank you very much yodon!

No, we are not referring to the production process validation. We ascertain that if there are some procedures that will slighly vary, we would need to re-validate or validate again such procedures. We are referring to safety and performance tests with animals (i.e. biocompatibility) and even humans (clinical study).
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?

thank you very much in advance!
 
Y

yodon

Staff member
Super Moderator
#4
#4
You always (just) need to demonstrate the product meets spec. (Of course, you need sufficient specifications to ensure efficacy.) Your in-process and final acceptance testing should provide sufficient evidence that the devices perform as expected. (And, of course, your in-process and final acceptance tests need to be sufficient to ensure compliance to spec.)
 
R

RegulatoryUS_EU

Registered
#5
#5
yodon said:
You always (just) need to demonstrate the product meets spec. (Of course, you need sufficient specifications to ensure efficacy.) Your in-process and final acceptance testing should provide sufficient evidence that the devices perform as expected. (And, of course, your in-process and final acceptance tests need to be sufficient to ensure compliance to spec.)
Click to expand...
thanks again yodon, really helpful.

therefore, if we demonstrate that in-process controls and final acceptance criteria reach the same results, we would have demonstrated that there are no differences in the devices? Could you provide an example of a difference that will jeopardise that both devices are the same?

many thanks, J
 
Y

yodon

Staff member
Super Moderator
#6
#6
That was why I put the 'satisfactory' caveats in. If you don't have sufficient specifications, maybe you allow the new factory to use materials that aren't biocompatibile. Maybe you don't have sufficient performance specs and you accept the new devices but they really don't operate the same. There are probably endless possibilities. You need to look at your specs and confirm they are sufficient enough to always ensure that the products built perform the same. Identify those critical performance specs, do a process FMEA to identify places where you could deviate, and set up proper manufacturing controls to ensure you're not making snowflakes.
 
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