Europe
This article has been updated May 29, 2025. The National Organization for Medicines (Εθνικός Οργανισμός Φαρμάκων – EOF) serves as Greece’s primary regulatory authority for medical devices, aligning with EU regulations including MDR 2017/745 and IVDR. EOF...
Europe
Article updated May 30, 2025. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) BfArM is Germany’s primary authority overseeing medical devices, aligning with EU regulations such as the Medical Device...
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...
Europe
In Croatia, the governmental body responsible for regulating medical devices is the Agency for Medicinal Products and Medical Devices (HALMED). Devices are categorized into the following classes based on the risk they pose toward on the human body: Class I, Class IIa,...
EU MDR/IVDR
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...
