EU MDR/IVDR
According to the information available, the implementation of Eudamed database could possibly be delayed for 2 years. Information on the delay was published for the first time after the medical device forum that took place in Hamburg. Eudamed: the Scope and Purpose...
EU MDR/IVDR
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to provide assistance to regulating authorities and...
Europe
European medical regulating authority, the EC, recently published a new guidance on medical device vigilance systems covering issues related to the distribution of information between national competent authorities. The document, intended to clarify definitions, set...
EU MDR/IVDR
European medical device regulating authority, the European Commission, issued two additional guidance. They expand on certain application aspects of Medical Device Regulation and in vitro Diagnostic Device Regulation. The new documents include important changes and...
