EU
The new article describes in detail the approach to be applied with respect to labeling for medical devices undergoing clinical evaluation.
Bahrain
The article highlights the key points related to the regulatory framework for implant cards as set forth under the current legislation.
EU
The new article describes in detail the second section of the document addressing mostly the matters related to the risks associated with a medical device and information to be provided in this respect.
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
EU
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
