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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
The FDA’s Center for Devices and Radiological Health (CDRH) may reject medical devices submitted for premarket approval when the agency is not satisfied that they have adequate cybersecurity, says Kevin Fu, who was appointed to the new position of the agency’s acting director of medical device security earlier this year. Read More
The FDA details its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances, including its criteria for ordering postmarket data collection. Read More
Canadian hospitals reported almost 3,500 medical device incidents to Health Canada in 2020, the agency said in a progress report on mandatory reporting requirements introduced as part of the agency’s Medical Device Action Plan. Read More
In the face of increasing cybersecurity threats, the Biden administration is taking several measures to implement stronger cybersecurity standards, including requiring software developers to improve the security of the software supply chain. Read More
The EU Medical Device Regulation (MDR), which went into effect on May 26, has caused some countries, including Switzerland, to lose direct access to the EU single market as they must update their mutual equivalency agreements in order to trade with the bloc. Read More