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Read moreIVDR
As of May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect.
Read morePractical information
Timelines:Application deadline: September 24, 2024 (15:00 CEST)
Notification of awards: December 2024
When & where do the meetings take place?Workshop 1:
Date: April 22-26, 2025
Venue: Cambridge, UK
CBTH session and EHA Congress:
Date: June 11-15, 2025
Venue: TBC
Workshop 2:
Date:…
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.
Read moreNews
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…
Advocacy priorities
The European Union works on countless pieces of legislation and policies that affect the health ecosystem. Some are relevant to most medical disciplines, including hematology—such as the legislation on health data or pharmaceuticals.
Read moreNew 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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