Denmark
The article outlines the key points to be included in the application for authorization to conduct clinical trials in Denmark.
Great Britain
The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
Great Britain
The new article describes in detail the new regulatory policy for in vitro diagnostic medical devices as suggested by the UK authority.
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 MDR/IVDR
This article highlights the importance of GSPR compliance for obtaining medical device approval in the European Market. Table of Contents The European Union (EU) has implemented stringent regulations and requirements for the approval and launch of medical devices...
