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

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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.
 

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