EU
The new article elaborates further on the aspects related to risk management in the context of medical devices to be used in the course of clinical investigations.
EU
The new article clarifies the aspects related to the pre-clinical evaluation the device should undergo before it will be allowed for use in patients.
EU
The new article describes in detail the approach to be applied with respect to labeling for medical devices undergoing clinical evaluation.
EU
The article highlights the key points related to the information the Investigator’s Brochure should contain in order to meet the relevant regulatory requirements.
EU
The new article provides comprehensive guidance on the reporting form to be used in the context of performance studies involving in vitro diagnostic medical devices.
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.
