EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
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...
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...
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...
EU MDR/IVDR
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 institution responsible for the regulation and...
EU MDR/IVDR
The institution responsible for medical device and pharmaceutical regulations in the United Kingdom is the Medicines and Healthcare products Regulatory Agency (MHRA). MHRA was formed in 2003 and its headquarters are located in London, England. In April 2013, MHRA...
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