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A Guide to Enter Your Medical Device in Italy
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation....
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,...
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...
A Guide to Enter Your Medical Device in Hungary
Medical devices in the EU, including Hungary, are classified into four classes based on their risk: I, IIa, IIb, and III. Medical devices belonging to Class I are associated with the lowest risk to the human body,...