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IVDR

As of May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect.

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New EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect

On May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) came into effect, mandating stricter and more comprehensive certification and testing protocols for in vitro diagnostic medical devices.

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News

New EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect

On May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) came into effect, mandating stricter and more comprehensive certification and testing protocols for in vitro…

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New HemaSphere publication on IVDR implementation

The In Vitro Diagnostic medical devices Regulation (IVDR), which came in to force in May 2022 with the objective of safeguarding the quality and safety of diagnostic tests in the EU, has a major impact on commercially available IVDs (CEIVDs) and…

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The invisible burden of the pandemic

Writing about my perspective on the COVID-19 pandemic has been on my mind for some time.

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The Clot Thickens

Haemophilia B is a genetic bleeding disorder, affecting approximately 80,000 males worldwide1, caused by an insufficient or dyfunctional blood clotting protein called factor IX (FIX).

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Highlights from the SWG

On November 24, 2022, the SWG on Red Cells and Iron held its annual Business meeting virtually which was chaired by Prof. Ali Taher and Prof. Achille Iolascon.

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Addressing the bureaucracy challenge

EHA has recently brought key stakeholders around the table to discuss bureaucratic obstacles in clinical research.

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