Regulatory Challenges for Blood Collection Tubes under EU IVDR in Germany
Introduction: EU IVDR and Its Impact on Blood Collection Tubes The regulatory environment for blood collection tubes under EU IVDR in Europe has undergone a fundamental transformation with the enforcement of the European Union In Vitro Diagnostic Regulation (EU IVDR 2017/746). Devices that were previously regulated as low-risk products under the In Vitro Diagnostic Directive […]
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