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
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