Great Britain
The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
Great Britain
The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.
Great Britain
The article provides a general overview of the UK regulatory framework for clinical investigations related to medical devices intended to be marketed and used in the country.
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.
