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The EU’s Medical Device Coordination Group (MDCG) has issued new advice to devicemakers on how to integrate EU unique device identification (UDI) requirements into their quality management systems. Read More
FDA Acting Commissioner Janet Woodcock has called for expanded authority to improve the agency’s ability to prevent medical device shortages. Read More
According to legal documents, Avanos falsely labeled its MicroCool surgical gowns as providing the highest level of protection against fluid and virus penetration. Read More
An EU expert panel has challenged a notified body’s clinical evaluation report, which is an additional element of conformity assessment for certain high-risk devices under the EU’s Medical Device Regulation (MDR), marking the first such challenge. Read More
The European Medicines Agency (EMA) has released guidance to devicemakers and notified bodies on how drug-device combination products should comply with the EU Medical Device Regulation (MDR) that came into effect on May 26. Read More
Nearly eight years after the FDA published its final rule on the unique device identification (UDI) system, it now has issued final guidance that describes the requirements for the form and content of the UDI system. Read More
The plain-text format is meant to allow anyone to read and enter the UDI into their data systems, such as for patient records or reports to the FDA without using a scanning device. Read More
Australia’s Therapeutic Goods Administration is proposing to ease certain requirements in its regulatory framework for custom-made and 3D-printed devices that became effective in February. Read More
Groups that will be impacted by the EU’s In Vitro Diagnostic Regulation (IVDR) are calling for urgent action to further delay its May 26, 2022 effective date and for a phased implementation. Read More