IVD Self Test Pregnancy - Assessment Route?

Z

zippyoh

Dear all,

I hope you can help?

We are an Importer of OB Self-Test IVD Pregnancy Test Kits, OEM in China. As this IVD is not listed in Annex II, are we able to take the Annex III conformity assessment route? We don't need Annex IV full QA - right?

Many thanks
 
Ronen E

Ronen E

Problem Solver
Moderator
zippyoh said:
Dear all,

I hope you can help?

We are an Importer of OB Self-Test IVD Pregnancy Test Kits, OEM in China. As this IVD is not listed in Annex II, are we able to take the Annex III conformity assessment route? We don't need Annex IV full QA - right?

Many thanks
Click to expand...

Hello and welcome to (posting on) the Cove :bigwave:

Devices that are not covered by Annex II are only subject to Annex III's requirements, as far as conformity assessment goes (excluding Performance Evaluation, which I understand is not the case).

Cheers,
Ronen.
 
Z

zippyoh

Ronen E said:
Hello and welcome to (posting on) the Cove :bigwave:

Devices that are not covered by Annex II are only subject to Annex III's requirements, as far as conformity assessment goes (excluding Performance Evaluation, which I understand is not the case).

Cheers,
Ronen.
Click to expand...
Hi Ronen,

Thanks for the welcome ☺

I was just informed today that if the OEM goes Annex IV the OBL must follow the same Annex IV assessment route. I haven't read this in the regulations or guidance docs???
The OEM manufactures Annex II listed products so I can understand the investment. We though, import and have NB certification for a range of OBL class 1 and are now looking to add the self-test pregnancy kit. I still don't get it

Best regards

Zippyoh
 
M

ManTheDan88

Your authorized representative is your best friend and source with questions like this. Also, you pay them so they kind of have to.
 
Ronen E

Ronen E

Problem Solver
Moderator
ManTheDan88 said:
Your authorized representative is your best friend and source with questions like this. Also, you pay them so they kind of have to.
Click to expand...

Zippyoh's profile indicates that the he/she is located in the UK, so I assume the company is there as well. A company based in the UK doesn't require an AR.
 
Ronen E

Ronen E

Problem Solver
Moderator
zippyoh said:
Hi Ronen,

Thanks for the welcome ☺

I was just informed today that if the OEM goes Annex IV the OBL must follow the same Annex IV assessment route. I haven't read this in the regulations or guidance docs???
The OEM manufactures Annex II listed products so I can understand the investment. We though, import and have NB certification for a range of OBL class 1 and are now looking to add the self-test pregnancy kit. I still don't get it ��

Best regards

Zippyoh
Click to expand...

Conformity assessment routes are determined per product, not per company. A company is entitled to go for higher routes across the board, but that doesn't change the regulatory requirements per product.

Having said that, if you intend to CE mark the kit as an OBL (with yourself named as the manufacturer, spun off the OEM's CE mark), I think it might be difficult / impossible to choose a route different from the one the OEM used for the original clearance. If they CE mark and you don't intend to go for your own, I think that the conformity assessment route they chose matters little to you.

Disclaimer: the IVDD Directive is not my specialty; I know it in a basic way.

Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T IVD Self-Test Notified Body Conformity Assessment Process EU Medical Device Regulations 0
T Clinical Study Design for IVD Self-Test (lay user) Products UK Medical Device Regulations 0
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 7
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 12
S Annex III self declared IVD to be in use with Annex II List B IVD EU Medical Device Regulations 1
R Data Analysis Software classified as MDSW IVD? EU Medical Device Regulations 3
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
M Multiple DMRs for IVD Medical Device and FDA Regulations and Standards News 0
A CE IVD Mark - Emission certifications for unexpensive product CE Marking (Conformité Européene) / CB Scheme 1
M Class III IVD PMA Amendment to FDA Medical Device and FDA Regulations and Standards News 1
M IVD Device Design Change Medical Device and FDA Regulations and Standards News 2
BusyBee IVD relabeling UK Medical Device Regulations 2
R Selling same device as IVD and RUO US Medical Device Regulations 8
R Selling same device as IVD and RUO EU Medical Device Regulations 1
C South Korea - MFDS registration for a Chinese IVD factory Other Medical Device Regulations World-Wide 4
K IVD Usability IEC 62366 - Medical Device Usability Engineering 4
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
S Registration of IVD in South Africa Other Medical Device Regulations World-Wide 2
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
R RUO and IVD Medical Device and FDA Regulations and Standards News 1
M UDI IVD - before submission? US Food and Drug Administration (FDA) 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
BusyBee IVD components supplied in bulk CE Marking (Conformité Européene) / CB Scheme 1
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
M Labeling IVD Class III Medical Device and FDA Regulations and Standards News 0
R IVD Label Change China Medical Device Regulations 1
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
D IVD Accuracy and Precision Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 1
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 4
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
S CE Marking components within IVD CE Marking (Conformité Européene) / CB Scheme 0
B IVD - GSPR checklist Other Medical Device Related Standards 0
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
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 5
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 5
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2

Similar threads

Top Bottom