UDI Compliance (Audit-Trail & Compliant Software) The implementation of the UDI system worldwide poses a challenge for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted and…
UDI Barcode & Correct UDI Labeling Identification and traceability of medical devices are crucial factors for patient safety and efficiency in the medical device industry supply chain. In this context,…
"Maximum number of reuses of device" in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the EUDAMED…
"Market Information": Meaning and Integration in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the FDA or…
Significant EUDAMED Update: New Timeline Heads up, everyone! There's been a shift in plans. EUDAMED's full functionality is now slated for Q2 2027. In late October 2023, the European Commission…
Clinical Size Types : Meaning and integration in EUDAMED The introduction of Unique Device Identification (UDI) has resulted in medical device manufacturers being required to provide health authorities such as…
Storage & Handling Condition: Key aspects and their significance The ever-evolving medical device industry is subject to comprehensive guidelines designed to ensure the safety and efficacy of healthcare products. With…
The introduction of the Medical Device Regulation brought a significant change: the assignment of Unique Device Identifiers (UDIs) for medical devices. This step was taken to improve the identification, traceability…
The European Database for Medical Devices (EUDAMED) plays a crucial role in the regulation and surveillance of medical devices within the European Union. With the introduction of the regulations (Art.…
The U.S. Food and Drug Administration (FDA) has taken a proactive step to ensure the accuracy and compliance of medical device information by notifying medical device manufacturers of potential discrepancies…