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MedTech Europe is urging the European Commission and EU member states to publish guidance that clarifies that notified bodies may conduct audits virtually in place of on-site audits during the COVID-19 pandemic for new devices and in vitro diagnostics. Read More
If the device’s medical effectiveness could be compromised by its non-medical functions, the manufacturer should consider the possible adverse effects on the device’s medical performance, the agency says. Read More
“This promising convergence of technologies offers an exciting opportunity to catalyze new approaches and solutions to improve patient outcomes, and we look forward to evaluating this device in a comprehensive clinical development program,” Ethicon said. Read More