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....
North America
On March 15, 2019, the US Food and Drug Administration (FDA) issued a final guidance document on medical devices using materials derived from animals. This documents intends to help manufacturers establish relevant procedures to lower the overall risk of infection...
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....
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
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...
EU MDR/IVDR
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 bring a device to market. These regulations are...
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