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The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations. Read More
MedTech Europe is warning European regulators that the EU’s new regulatory system for devices won’t be ready on time and said the delay will jeopardize patient lives. Read More
“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the agency said. Read More
The agency now considers the definition of convenience kit “to mean a device that contains two or more difference medical devices packaged together and intended to remain packaged together.” Read More
CDRH released guidance on what information should be included in regulatory submissions for devices that generate quantitative imaging values. Read More