Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the reporting of computational modeling studies in medical device submissions. The latest version of...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has issued a guidance document dedicated to the procedures for handling post-approval studies imposed by premarket approval application orders. The...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to the non-clinical testing and clinical considerations of implanted brain-computer interface devices. The present...
