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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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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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EHA24 is YOUR congress – here’s how you can make the most of it

Congress season is an exciting time for any field. It’s a time when experts come together to share the latest developments, and also an opportunity to see friends and colleagues who you haven’t seen in a while.

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Without access to treatment, can we truly innovate in rare diseases?

Interview with Giampaolo Merlini

There have been many developments on rare diseases since the EU Orphan Medicinal Products Regulation came into force in 2000. As the European Commission is evaluating its effectiveness, EHA discussed with Prof.

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EHA response to the EU’s Pharma Revision

Last week, the European Affairs team finalised EHA's response to the proposed revision of the EU (European Union) Pharmaceutical Legislation. In April 2023, the European Commission published a proposed Directive and Regulation to replace the current, outdated legal framework.

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