SBS - The best value in QMS software

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
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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 6
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
S Annex III self declared IVD to be in use with Annex II List B IVD EU Medical Device Regulations 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 0
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 4
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 9
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
J IVD CE transfer to another manufacturer EU Medical Device Regulations 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
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
T MDD and IVD comparison Other Medical Device Regulations World-Wide 2
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
ernieto CE marked IVD - Does the "IVD" symbols needs to be in the IFUs? CE Marking (Conformité Européene) / CB Scheme 2
F IVD: Overlabeling in the EU? EU Medical Device Regulations 4
F EU IVD registrations - CFG or CFS - Differences EU Medical Device Regulations 1

Similar threads

Top Bottom