Great Britain
The new article describes in detail the new regulatory policy for in vitro diagnostic medical devices as suggested by the UK authority.
Great Britain
The article highlights the key points associated with the concept of common specification requirements for certain products allowed to be marketed and used in the UK.
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.
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
