Mar 23 - 12:24
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...
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 - 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...
Feb 28 - 8:10
This article provides a general overview of the current medical device regulations in the Czech Republic. The State Institute for Drug Control, or Státní ústav pro kontrolu léčiv (SUKL) in Czech, is the government...
