Tag: European Regulators

Healthcare, Industry News, Medical Devices, Regulatory Affairs

Four organizations designated as UDI Issuing Agencies by EC

The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements applicable for Medical Devices under the Medical Devices Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices (EU) 2017/746 (IVDR). These agencies will issue the unique codes necessary for […]

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