RegDesk Regulatory Roundup

MDCG Guidance on UDI Integration EU MDR/IVDR

MDCG Guidance on UDI Integration

The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the integration of the UDI within organizations’ quality management systems. The MDCG...

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FDA Guidance on Recalls FDA

FDA Guidance on Recalls

The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for marketing approval and post-market monitoring and surveillance in the sphere of medical devices, has published an official notice dedicated to special action taken to...

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