FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
EDA
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
MHRA
The new article describes in detail the specific requirements an application should meet, as well as the relevant steps and procedures.
BfArM
The article addresses the aspects related to data protection in the context of digital health applications.
