IVD Self Test Pregnancy - Assessment Route?

Z

zippyoh

#1
#1
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
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
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

#3
#3
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

#4
#4
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
Staff member
Moderator
#5
#5
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
Staff member
Moderator
#6
#6
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.
 
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