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 19 - 4:01
European Commission informed that as a result of implementation of medical device and in vitro diagnostic regulations, there could be an issue of availability of several types of devices. The root of the problem is due...
Mar 23 - 12:24
MEDICAL DEVICE REGULATIONS IN FINLAND Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to...
