IVD CE transfer to another manufacturer

J

Joonseok

Registered
#1
#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
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Joonseok said:
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
Click to expand...
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

shimonv

Trusted Information Resource
#3
#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
 
J

Joonseok

Registered
#5
#5
shimonv said:
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
Click to expand...
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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 0
T CE-IVD mark on packaging EU Medical Device Regulations 1
A Is computing Hardware part of the IVD CE Marking (Conformité Européene) / CB Scheme 3
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
Y Handbook recommended lightcycler for IVD Risk Management Principles and Generic Guidelines 1
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 3
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
G CE marking of MD and IVD set EU Medical Device Regulations 3
D List A IVD - Change to material supplier EU Medical Device Regulations 3
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
J IVD instrument as an accessory EU Medical Device Regulations 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 10
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
M EU IVD Risk Determination of sample collection EU Medical Device Regulations 0
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
D RUOs in IVD products Other Medical Device and Orthopedic Related Topics 2
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
M IVD Registration - Use of Prospective Study Data Other Medical Device Regulations World-Wide 1
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
I IVD prototypes in EU market ISO 13485:2016 - Medical Device Quality Management Systems 2
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
M IVD - Generating clinical data for IVD’s in the EU EU Medical Device Regulations 2
K Validation of coating plate (IVD) CE Marking (Conformité Européene) / CB Scheme 3
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0

Similar threads

Top Bottom