FDA
The new article provides additional clarifications with respect to the development of use-related risk analyses.
FDA
The new article elaborates further on the submission of use-related risk analyses, and also provides certain examples intended to demonstrate the way the regulatory approach described in the guidance should be applied.
EU
The document outlines the approach to be followed in order to ensure standardisation for medical devices, facilitating further harmonisation of the relevant regulatory requirements.
EU
The new article describes in detail the relevant harmonised standards applicable to medical devices, and also the way they should be applied.
Australia
The article highlights the key points related to the application of certain essential principles intended to ensure the safety and proper performance of healthcare products allowed to be marketed and used in Australia.
