United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
MHRA
The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. Table of Contents The Medicines and Healthcare Products Regulatory...
FDA
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
FDA
The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...
MHRA
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
