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Although many diagnostics firms were hoping that the effective date of the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) would be further delayed, the EU Medical Device Coordination Group (MDCG) unveiled a joint implementation and preparedness plan for the IVDR indicating that the new requirements will go into effect as planned. 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 Breakthrough Device designation is intended to give patients more timely access to new devices by expediting their development and review. Read More
In an executive order, President Biden said the development of commercial software “often lacks transparency, sufficient focus on the ability of the software to resist attack and adequate controls to prevent tampering by malicious actors.” 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 maintain greater visibility in their supply chains and make security data publicly available. Read More
The European Commission has launched an online helpdesk for devicemakers who must comply with the new unique device identification (UDI) system introduced under the EU Medical Device Regulation (MDR), which went into effect on May 26. 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
The FDA has studied how South Korea handled authorizations of COVID-19 diagnostic tests, hoping to learn from that country’s early success in dealing with the virus. Read More