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EU MDR: Ensuring Labeling Compliance

Leave a Comment / 05-Quality/Regulatory, EU MDR, Labeling, MDR/IVDR, Medical Device, medical devices, MedTech, RC - EU MDR and IVDR, RC - Medical Device Labeling, UDI / By

EU MDR: Ensuring Labeling Compliance      In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow market readiness and lack of notified bodies, and  grants companies additional flexibility to meet the demand for safe, innovative …

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Life Sciences Labeling for Patient Safety

Leave a Comment / device labeling, enterpise labeling, EU MDR, FDA, Medical Device, MedTech, patient safety, RC - Medical Device Labeling, Soapbox, Top Clean Injection, UDI / By

Life Sciences Labeling for Patient Safety     Labeling regulations from the FDA and European Union (EU) are continuously changing to protect public health and improve patient safety. The Drug Supply Chain Security Act (DSCSA) enhances FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. These …

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