Change of Manufacturing Location




Our company is preparing a dossier for getting CE mark.
Let me give you detail situation.

There are two facilities (A, B (x 7 times scale up) and the distance is only 20 minutes by a car.
Our product is classified to Class III, but is not registred.
We conducted a clinical trial to support our indication and several non-clinical testings with a product from the facility A (There is no clinical/nonclinical data from the facility B). A couple of the non-chlinical tests are not satisfied the MD regulation.
All validations related the process, quality will be done in the facility B.

Here are my basic questions.
Our company will be register the facility B for commercical products.
For this, we will filed all data, CMC, clinical/non-clinical data in facility A and stability data in facility B. In addition, the equivalent data (manufacturing process and quality) between two facilities will be included.

Question No.1
The non-clinical tests not meet to the regulation will be included after doing new tests with the product manufactured from the facility B in case of we verify the equivalance.
Will it be possible for registration as a regulatory aspect?
Do we have to do the non-clinical tests with the product produced from the facility A?

Question No.2
What is the best way to register our product using all data we have?
I know some tests must be performed, but I don't think the clinical test will be not.

I hope you can help me a lot.



Hi Eelleseo.
Thanks for your good question and welcome to the Cove.
While someone expert with the EU regulations will pitch in, my advice to you is to open up all your questions with your NB.... for your NB is the one who provides the gateway to the EU with the CE mark.


Thanks for your reply.
You are right, but our NB is not a good responsor. It takes too long to give us the reponse to us.


Involved In Discussions
Best approach (as indicated to be followed by you):
Identify for each tests which products (from what site) are used.
Demonstrate through testing which ER is covered (or more)
In case product tested comes from A, argue how it covers the final design specifications. Same applies to products tested from site B.

In case you need more detailed guidance, I am afraid you need to provide more detailed information.


Hi RobertvanBoxtel,

Thank you for your valuable opinion.
I am afraid how much I should prepare the reasonable document for that.


Involved In Discussions
Transferring from one site to the other requires a lot of evidence to demonstrate continuous control.
And to be able to demonstrate something, yes, documentation is needed. Because if you cannot demonstrte it on paper (or electronically), it ain't done...


Trusted Information Resource
My thoughts on this are as follows:

the locations of manufacture are somewhat irrelevant at this stage as the device is not approved; you must be able to show/prove (and this is no different from if you were using the same site):

1. The products you manufacture for the clinical study at site A are as intended by the design specification (otherwise how you you prove the design is safe/effective)
2. Your device that is manufactured as intended by the design spec is safe and effective (this is the purpose of the clinical evaluation
3. The product you manufacture at the main production site (B) comply with the design specification that was used as part of the clinical evaluation (i.e. the product continues to be safe and effective)

The main concern of the notified body will be "how do you know that product produced at site B is the same as the product at site A"

Things to consider (this is not a complete list)
- are all components sourced from the same place, do they go through the same or more rigorous inspection checks
- are all the in process controls the same (or more rigorous)
- is the batch release criteria the same?
- is packaging the same specification
- is the sterility still assured?
- is equipment calibrated to the necessary level
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