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How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping

#1
Seeking guidance on the following relevant standards to ensure need and requirements of the standard ISO 13485;2016 clause wise are met ;

1. ISO 13485:2016 - Requirements for regulatory purposes
2. EN 13641: 2002 - Elimination or reduction of risk of infections related to IVD reagents.
3. EN ISO 14671: 2012 - Application of risk management to medical devices
4. EN 13612:2002 - Performance evaluation of IVD medical devices.
5. EN 23640:2013 - IVD-MD- Evaluations of stability of IVD reagents.
6. EN 15223-1:2012 : MD symbols to be used with medical device label.
7. EN ISO 18113-1, -2 " 2011 IVD-MD- Information supplied by the manufacturer (labeling)

The medical device is classified as;
IVDs in Annex II List A – High Risk
For devices under Annex II List A, manufacturers must follow either Annex IV, or alternatively Annexes V and VII (they cannot follow Annexes V and VI). In addition, the Notified Body must verify the product meets the Common Technical Specification (CTS) and must release each batch of product before it can be placed on the European market. The batch release often requires testing.
 

kj_wilson

Optimistic Global Curmudgeon
#2
Seeking guidance on the following relevant standards to ensure need and requirements of the standard ISO 13485;2016 clause wise are met ;

1. ISO 13485:2016 - Requirements for regulatory purposes
2. EN 13641: 2002 - Elimination or reduction of risk of infections related to IVD reagents.
3. EN ISO 14671: 2012 - Application of risk management to medical devices
4. EN 13612:2002 - Performance evaluation of IVD medical devices.
5. EN 23640:2013 - IVD-MD- Evaluations of stability of IVD reagents.
6. EN 15223-1:2012 : MD symbols to be used with medical device label.
7. EN ISO 18113-1, -2 " 2011 IVD-MD- Information supplied by the manufacturer (labeling)

The medical device is classified as;
IVDs in Annex II List A – High Risk
For devices under Annex II List A, manufacturers must follow either Annex IV, or alternatively Annexes V and VII (they cannot follow Annexes V and VI). In addition, the Notified Body must verify the product meets the Common Technical Specification (CTS) and must release each batch of product before it can be placed on the European market. The batch release often requires testing.
Seeking guidance on the following relevant standards to ensure need and requirements of the standard ISO 13485;2016 clause wise are met ;

1. ISO 13485:2016 - Requirements for regulatory purposes
2. EN 13641: 2002 - Elimination or reduction of risk of infections related to IVD reagents.
3. EN ISO 14671: 2012 - Application of risk management to medical devices
4. EN 13612:2002 - Performance evaluation of IVD medical devices.
5. EN 23640:2013 - IVD-MD- Evaluations of stability of IVD reagents.
6. EN 15223-1:2012 : MD symbols to be used with medical device label.
7. EN ISO 18113-1, -2 " 2011 IVD-MD- Information supplied by the manufacturer (labeling)

The medical device is classified as;
IVDs in Annex II List A – High Risk
For devices under Annex II List A, manufacturers must follow either Annex IV, or alternatively Annexes V and VII (they cannot follow Annexes V and VI). In addition, the Notified Body must verify the product meets the Common Technical Specification (CTS) and must release each batch of product before it can be placed on the European market. The batch release often requires testing.


=-=-=-= RESPONSE =-=-=-=-=
In general, all of the listed standards could be relevant (useful). A bit more info is needed to answer your question. Feel free to use the forum for our discussion, or respond via "private msgs" if you wish.
  1. What is the Intended Use (Indication for Use) of the Product?
  2. What markets is the product intended (EU, JP, CA, US, ...)?
  3. Is the product (or a very similar, in terms of technology) marketed anywhere (include if it is a research-only) product)?
 
#3
Hi,
1) product are distributed to hospital, blood bank and clinical research.
2) only in Saudi Arabia. In Saudi Arabia, the regulatory body is SFDA ( Saudi Food and Drugs Authority) similar to FDA.
3) Yes.- Reagent kits are processed as per customer's specification and control by "contract manufacturing" and distribution.
 

kj_wilson

Optimistic Global Curmudgeon
#4
It has be a couple of years since I was involved with IVD products in Saudi Arabia, so please double check their regs. I believe that your jurisdiction is structured similar to the EU/JP mode of regulation.

As such, there are two main standards to be concerned with first:
  • ISO 13485:2016
  • ISO 14971:2012 {I think you have a typo in your original post...}

Get your systems for those two in order, then communicate with the SFDA directly about what sort of assurances they want to see to approve your product(s). Then decide if the existing global (ISO) standards are suitable for meeting those requirements.

NB: products used "FOR RESEARCH ONLY" have their own collection of concerns; it possible, it is best to use fully approved human IVD products in clinical research settings (especially if they will be supporting healthcare decisions or used as evidence for approval of other devices/drugs).

Hoping this helps...
 

kj_wilson

Optimistic Global Curmudgeon
#5
I presumed that you have completed the "Essential Principles Checklist" (GHTF/IMDRF) required by SFDA, if not, start there.
 
#7
It has be a couple of years since I was involved with IVD products in Saudi Arabia, so please double check their regs. I believe that your jurisdiction is structured similar to the EU/JP mode of regulation.

As such, there are two main standards to be concerned with first:
  • ISO 13485:2016
  • ISO 14971:2012 {I think you have a typo in your original post...}

Get your systems for those two in order, then communicate with the SFDA directly about what sort of assurances they want to see to approve your product(s). Then decide if the existing global (ISO) standards are suitable for meeting those requirements.

NB: products used "FOR RESEARCH ONLY" have their own collection of concerns; it possible, it is best to use fully approved human IVD products in clinical research settings (especially if they will be supporting healthcare decisions or used as evidence for approval of other devices/drugs).

Hoping this helps...
Thanks for the guidance. Let me review and revert back, in case need your support for consultancy.
 
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