Mar 11 - 2:38
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...
Mar 6 - 8:23
On December 7th, 2018, Team NB, an organization of European Notified Bodies (NBs), published a document titled “Joint NB-Position Paper on Spinal Classification per the MDR” that summarizes their opinion on Rule 8 of...
Mar 6 - 2:38
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...
Mar 6 - 12:48
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...
Mar 5 - 11:32
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...
