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Blood typing for IVDR
Validation of ABO, RH, Duffy and Kell blood group analyzes prior to IVDR approval.
Purpose
The regulation for in vitro diagnostics (IVDR – EU 2017/746) aims to ensure and streamline diagnostic tests on the European market. The IVDR was adopted in April 2017 and became fully applicable on May 26, 2022. All new IVD devices must therefore meet the requirements of the IVDR before being placed on the market. Likewise, IVD devices that were on the market before 26 May 2022 must be validated and approved in accordance with the IVDR.
The IVDR has resulted in stricter classification rules and thus also a greater need for Notified Bodies (NB). All IVD units require approval from NB. At RISE, we can validate IVD products within blood typing that belong to class D, prior to approval in accordance with the IVDR.
Method
Identification of AB0-RH, Duffy and Kell systems by agglutination.
Delivery
The result is reported in a validation report with a compilation of results.