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AEMPS Applies for NB Designation
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...
EMA Releases Guidances Addressing Drug Shortages
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...
MedTech Published a Detailed Plan Regarding MDR/IVDR
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...
The EMA Published Draft Guidance on DDC Products.
European Medicines Agency issued a new draft guidance related to drug-device combinations.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...