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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…
Read moreRegulatory affairs & scientific relations
EHA’s regulatory work: European Medicines AgencyMost of EHA’s regulatory work entails collaboration with the European Medicines Agency (EMA).
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