Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
EU MDR/IVDR
The European Medicines Agency (EMA) recently released a guidance document regarding the new EU MDR, which will go into full effect in May 2020. This guidance focuses on the responsibility manufacturers will take in the registration process for combination devices with...
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,...
Europe
In Bulgaria, the institution that regulates medical devices is the Bulgarian Drug Agency (BDA). On June 12, 2007 the Bulgarian Parliament created the Law on Medical Devices, which is the policy that is currently used to govern the registration of medical devices...
