IVD CE transfer to another manufacturer

#1
Hi,
We are small IVD (BGMS) manufacturer in South Korea.

<Status>
Another manufacturer("A") manufactures and sells the product (Blood Glucose Monitoring System) into the market. The product is CE certified and this manufacturer("A") has ISO 13485 certifiacte.
We are also BGMS manufacturer and our product is CE certified and we have ISO 13485 certificate.

We consider that we receive this product from the manufacturer("A") officially. "A" plans to discontinue to manufacture and sell this product if transfer completed, and we are planning to manufacture and sell this product in same specification in our manufacturing site. (Product name & labelling will be changed)

<Queries>
1. In this case, Is this kind of CE transfer from manufacturer to another manufacturer possible?
2. If possible, what procedures both manufacturers have to follow? (Both manufacturer has different NBs)
3. Should we prepare Technical Files and is it to be reviewed by NB? (which NB?)

Thank you in advance.

Regards,
Joonseok
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,
We are small IVD (BGMS) manufacturer in South Korea.

<Status>
Another manufacturer("A") manufactures and sells the product (Blood Glucose Monitoring System) into the market. The product is CE certified and this manufacturer("A") has ISO 13485 certifiacte.
We are also BGMS manufacturer and our product is CE certified and we have ISO 13485 certificate.

We consider that we receive this product from the manufacturer("A") officially. "A" plans to discontinue to manufacture and sell this product if transfer completed, and we are planning to manufacture and sell this product in same specification in our manufacturing site. (Product name & labelling will be changed)

<Queries>
1. In this case, Is this kind of CE transfer from manufacturer to another manufacturer possible?
2. If possible, what procedures both manufacturers have to follow? (Both manufacturer has different NBs)
3. Should we prepare Technical Files and is it to be reviewed by NB? (which NB?)

Thank you in advance.

Regards,
Joonseok
1. No.
2. N/A (however, "A" could support you a lot in obtaining certification/clearance for their (ex-)product under your manufacturing.
3. Yes, yes, your NB.
 

shimonv

Trusted Information Resource
#3
I agree with Ronen. I will just add that you should do a very thorough quality audit of Manufacture "A" to make sure that the transition from QA/RA prospective is not going to be very difficult. Also, please consult your NB to better understand their expectations; quit likely you might need to certify the new product according to MDR.

Shimon
 
#5
I agree with Ronen. I will just add that you should do a very thorough quality audit of Manufacture "A" to make sure that the transition from QA/RA prospective is not going to be very difficult. Also, please consult your NB to better understand their expectations; quit likely you might need to certify the new product according to MDR.

Shimon
Thanks for your opinion, Shimon. I asked our NB and they answered as the product addition with change notification will be required, and newly added product's technical files and related manufacturing documents will be reviewed during next audit or surveillance phase.
 
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