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Overview of Ireland’s Registration Process
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland,...
RMAT Designation: The Requirements and Benefits
The 21st Century Cures Act was groundbreaking and brought limitless possibilities to the field of medical treatment.  Regenerative medicine advanced therapy, or RMAT, designations were created under this act to provide...
Guide to Enter Your Medical Device in Portugal
Portugal, as a member of the European Union follows the same medical device classification as all other EU member states. In the EU classification system we can distinguish four different medical device classes: Class...