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Our Guide to Registering Medical Devices in Croatia
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...
Overview of Medical Device Regulations in Bulgaria
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...
The US and EU Collaborate on UDI Specifications
According to the interim report on the work of the Executive Working Group (EWG), the European Union and United States will work together to make sure their electronic database specifications for Unique Device...
Implementation Timelines for EU MDR and IVDR
On May 5th, 2017 the European Union Medical Device Regulation (EU MDR) was officially published and was entered into force on May 26th, 2017. The new regulation, which is binding in its entirety, will have a direct...