EU MDR/IVDR
Statens legemiddelverk, the Norwegian Medicines Agency, issued an official notice to warn all parties involved in operations with medical devices that have been delayed in the launch of the new European database – EUDAMED. EUDAMED Delay EUDAMED is a database...
North America
The US medical device regulating authority, the FDA, issued a Safety Communication on medical devices used for monitoring glucose levels. These devices are primarily used by patients with a high risk for diabetes. The warning covers a wide range of devices including...
