Europe
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, such RA is HPRA. Overview All medical...
Europe
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 I, Class IIa, Class IIb, and Class III. Class 1...
Europe
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, while Class III devices are associated with the...
Europe
Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III....
Europe
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), BfArM, is the institution responsible for regulating medical devices in Germany. Headquartered in Bonn, BfArM operates under the Federal Ministry of Health....
Europe
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 bring a device to market. These regulations are generally quite complex, but such complexity...
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