Jul 12 - 3:37
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....
Jul 9 - 5:50
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device...
Jul 8 - 6:23
On Friday, the European Medicines Agency (EMA) released two guidance documents addressing issues surrounding drug shortages in the EU, and how to manage drug shortages publicly. These documents were created by a task...
Jul 2 - 3:11
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....
Jun 21 - 3:56
European trade association, MedTech Europe, published a detailed plan. It aims to help the member states speed up and simplify the process of implementation of new MDR/IVDR regulations. The plan intends to assist...
Jun 4 - 5:14
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of...
